MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-05 for PROLIEVE THERMODILITATION SYSTEM M0068808170 manufactured by Boston Scientific - Marlborough.
[2627412]
It was reported to boston scientific corporation that a prolieve thermodilitation system kit was used during a benign prostatic hyperplasia (bph) procedure. According to the complainant, during the procedure, the physician reported that they were not able to insert the catheter tip into the patient's penis because the catheter tip was too flimsy. They tried to insert the catheter into a cystoscope with a guide wire, but the catheter still could not be inserted. The physician aborted the procedure. There were no complications and the patient's condition was reported as fine. Follow up with the complainant revealed the tip was really soft and the tip buckled even with the guide wire through it.
Patient Sequence No: 1, Text Type: D, B5
[2662087]
It was reported to boston scientific corporation that a prolieve thermodilitation system kit was used during a benign prostatic hyperplasia (bph) procedure. According to the complainant, during the procedure, the physician reported that they were not able to insert the catheter tip into the patient's penis because the catheter tip was too flimsy. They tried to insert the catheter into a cystoscope with a guide wire, but the catheter still could not be inserted. The physician aborted the procedure. There were no complications and the patient's condition was reported as fine. Follow up with the complainant revealed the tip was really soft and the tip buckled even with the guide wire through it.
Patient Sequence No: 1, Text Type: D, B5
[9608459]
(b)(4) for the reported event of device tip bent. (b)(4) for the reported event of device catheter folded. (b)(4) for the reported event of device catheter difficult to insert.
Patient Sequence No: 1, Text Type: N, H10
[9976131]
A review of the manufacturing records for this lot showed no evidence of a manufacturing-related potential cause for this event. The returned catheter was the legacy style catheter with a blunt tip, not the coude tip. Product analysis found no issues with the returned device. The legacy style catheter lot # 681212 was distributed with kit lot # 689751, which expired in june 2011. The procedure date for this complaint is (b)(4) 2012, indicating the customer used an expired prolieve kit to perform this procedure. The prolieve system directions for use (dfu) instructs the user to ''inspect the kit packaging for physical damage and expiration date prior to use'' as part of the instructions for use. Additionally, the event description indicates the customer tried to insert the catheter into a cystoscope with a guide wire to place it in the patient's prostate. When the catheter cannot be inserted without the use of a guide wire, the instructions for use section of the dfu suggests the physician use a cystoscope for placement of a guide wire. The guide wire can then be used to place the catheter through the bladder access lumen. The dfu does not instruct the user to place the catheter in the cystoscope, because doing so could cause injury to the patient. The most probable root cause for the use of expired product and the placement of the catheter into the cystoscope is user error. Although the kit was used past its expiration date, product analysis found no problems with the returned device. The product analysis showed no evidence of the alleged issues or any defect which could have contributed to the event; therefore, the root cause for this complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2012-00616 |
| MDR Report Key | 2477887 |
| Report Source | 05,07 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-10 |
| Date of Event | 2012-01-20 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2009-11-24 |
| Date Added to Maude | 2012-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLIEVE THERMODILITATION SYSTEM |
| Generic Name | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY |
| Product Code | MEQ |
| Date Received | 2012-03-05 |
| Returned To Mfg | 2012-02-16 |
| Model Number | M0068808170 |
| Lot Number | 0000689751 |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-05 |