MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-06 for THE SPANNER TEMPORARY PROSTATIC STENT SURV-02 manufactured by Abbeymoor Medical Inc..
[1704221]
A sales rep called to seek advice about a surveyor that was stuck in a patient after the physician attempted to take a measurement for the insertion of a spanner. The physician confirmed the balloon was deflated prior to the removal attempt via ultrasound. The physician then viewed the urethra with a cystoscope and concluded the surveyor had gone down a false passage. With the aid of the cystoscope, the physician was able to remove the surveyor. The physician attempted the measurement with a different surveyor, was successful and a spanner was placed. The sales rep called after the procedure to state the pt appeared to be doing well. The sales rep spoke to the physician on (b)(4), five days after spanner placement. The physician reported the patient voided great for two days then had to go to the er because he went into retention. Physician feels a clot had clogged the stent. No further f/u info regarding the pt has been received. Indication for use was post transurethral incision of the prostate (tuip); time frame since tuip is unk. Pt presented with a catheter prior to spanner measurement and insertion.
Patient Sequence No: 1, Text Type: D, B5
[8670713]
Eval summary: (b)(6) medical requested the device be returned for eval. The device was subjected to a visual examination and functional testing. Returned device analysis showed the surveyor device appeared to function normally with the exception of the wire movement. This was caused by a severe bend in the probe wire. The cause of the bend in the wire is unk but was most likely due to manipulations required during the surveyor removal. The components measured met specification. The device profile met current design specifications. The balloon inflation and deflation time met specifications. Dhr review was not done based on the complaint, also lot number of device is unk. The sales rep that observed the spanner measurement process stated the device appeared to function normally until removal was attempted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00004 |
| MDR Report Key | 1813662 |
| Report Source | 05 |
| Date Received | 2010-08-06 |
| Date of Report | 2010-08-11 |
| Date of Event | 2010-07-09 |
| Date Mfgr Received | 2010-07-09 |
| Date Added to Maude | 2012-03-12 |
| 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 | MER |
| Date Received | 2010-08-06 |
| Returned To Mfg | 2010-08-04 |
| Model Number | SURV-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-08-06 |