MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-02 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-6CA manufactured by Abbeymoor Medical Inc..
[1064565]
Patient had spanner placed following his transurethral microwave thermotherapy (tumt) procedure for benign prostatic hyperplasia (bph) by reporter. Device was placed in 2008 in the office. Patient was unable to void the same day, and presented to the er that evening. The physician there placed a foley catheter without first removing the spanner device. This placement of the foley pushed the spanner device into the patient's bladder. Dr(reporter) was contacted and scheduled an appointment with the patient for the following month, and subsequently removed the device from the patient using flexible cystoscopy six days later. The device balloon was still inflated when dr went into the bladder to retrieve it. The doctor grasped the black retrieval tether, reseated the device in the prostatic urethra and proceeded with a normal device removal from that point. The patient had a follow up visit the following month, and was doing well with no additional notes in the patient's chart from dr.
Patient Sequence No: 1, Text Type: D, B5
[8253535]
The device was not returned for evaluation. A review of device history records (dhr) for this spanner lot revealed no indication that the device used did not meet specifications. Based upon a discussion with the physician after the event occurred, he was not sure why the patient would have gone into urinary retention with the device in place. He was pretty confident that the device was pushed into the bladder by the placement of the foley at the er. He was not concerned about immediate retrieval of the device and this can be seen by the follow up event dates with the patient. Mfr requested that he save the device to send it back for evaluation and also had requested he record the cystoscopic removal of the device. In the follow up with him, he stated that he had forgotten to do this but that the removal went fine, and that the balloon was still inflated when he went to retrieve the device. He stated that he saw nothing remarkable about the device and that it seemed to be in good working order and reaffirmed that he felt the placement of the foley is what caused the device to migrate into the patient's bladder. Conclusion: device not returned. No evaluation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00012 |
| MDR Report Key | 1350846 |
| Report Source | 05 |
| Date Received | 2009-01-02 |
| Date of Report | 2008-12-31 |
| Date of Event | 2008-09-21 |
| Date Mfgr Received | 2008-09-24 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-06-25 |
| 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 Street | 501 EAST SOO STREET |
| Manufacturer City | PARKERS PRAIRIE MN 56361 |
| Manufacturer Country | US |
| Manufacturer Postal | 56361 |
| Manufacturer Phone | 2183386700 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | TEMPORARY PROSTATIC STENT |
| Product Code | NZC |
| Date Received | 2009-01-02 |
| Model Number | SPNR- |
| Catalog Number | SPNR-6CA |
| Lot Number | 1 |
| Device Expiration Date | 2011-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-02 |