MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-04-09 for BIOSNDSTR10 manufactured by Sterilmed, Inc..
[5669731]
It was reported that during a paroxysmal atrial fibrillation procedure (afib), a perforation was noticed as the patient's blood pressure dropped. The perforation was confirmed by ultrasound. A pericardiocentesis was performed and approximately 1050 ml of fluid were removed. Protamine was administered. The patient was reported to be in stable condition. It was later reported that the device was in the right atrium, and a sound map had been taken with the device. An ablation catheter was used to go transseptal and mapping was started with the ablation catheter along the roof line of the left atrium. There appeared to be a lot of pressure on the ablation catheter. It was at this point when the blood pressure dropped. The procedure was completed. The patient did not required extended hospitalization and was discharged the following day. There were no reported malfunctions of the device during the procedure. We are taking a conservative approach and reporting this event because a sterilmed device was used in mapping.
Patient Sequence No: 1, Text Type: D, B5
[13183560]
Concomitant medical products: the following biosense webster products were also used during the procedure: carto 3 (14652), stockert (s/n unknown) cool flow pump (s/n unknown), smarttouch catheter (d133602, 17125402m), lasso catheter (d7l1015ct, 17173874l), lasso eco catheter (d134301, 17150127l), lasso eco catheter (d134904, 17159560l), mobicath (d140010, w2891844), cs catheter (d610drp10rt, 1704047m) the device was received by the manufacturer and is being evaluated. A supplemental report will be filed when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33002593]
The device was returned to the manufacturer coiled in a plastic bag. Final device investigation found that the returned device had a kink in the shaft. Upon evaluation, the device passed all functional testing, including all mechanical and electrical testing. The device history record was reviewed, and no discrepancies were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00016 |
| MDR Report Key | 4674327 |
| Report Source | 08 |
| Date Received | 2015-04-09 |
| Date of Report | 2015-03-13 |
| Date of Event | 2015-03-13 |
| Date Mfgr Received | 2015-04-23 |
| Device Manufacturer Date | 2014-12-04 |
| Date Added to Maude | 2015-04-09 |
| 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 | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY, SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2015-04-09 |
| Returned To Mfg | 2015-04-07 |
| Model Number | BIOSNDSTR10 |
| Catalog Number | BIOSNDSTR10 |
| Lot Number | 1821268 |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-09 |