MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-09-30 for SUBMARINE RAPIDO SBR070030135 manufactured by Invatec Spa.
[16306046]
It was reported that a physician was attempting to treat a lesion using submarine rapido pta balloon. The device was advanced to target lesion, but physician was unable to deploy the balloon. Physician used a non-mdt device to complete surgery. No patient injury or other sequelae were reported for this event. When the device was returned to the manufacturing facility, the balloon of the device was noted to be damaged. Device evaluation: the device was returned with the original box and pouch, inserted in its hoop. The protection tube was mounted on the balloon; however it was removed in order to perform analysis. No traces of blood or radio opaque solution detected on the device. The guide wire lumen was stretched and damaged in two points; the first point was proximally to the proximal marker band, where the guide wire was crushed, and the second close to the end of the protection stylet inserted, where the guide wire was stretched. After the removal of the stylet the guide wire lumen stretched over the stylet crushed resulting impossibility to insert the gw. An attempt to inflate the balloon was performed using a manometric syringe. Negative pressure was applied and a leakage was detected due to a column of bubbles raise in the syringe. The balloon was inflated at 7 bar and a pinhole was detected on the surface, close to the proximal side of the cylindrical part. The guide wire could not be passed all length long due to several damaged part of the guide wire lumen. Another kinked point was detected on the shaft, close to the hypotube. No other abnormalities detected on the device. ? Please note that this device (submarine rapido) is distributed outside the united states; however, it is similar to the united states distributed product (submarine plus).?
Patient Sequence No: 1, Text Type: D, B5
[16385782]
Evaluation codes results: (based on limited information received, root caused in undetermined). Deformation problem. Evaluation conclusion: (based on limited information received, root caused in undetermined). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004066202-2014-00162 |
| MDR Report Key | 4127436 |
| Report Source | 01,05,07 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-08-01 |
| Date Mfgr Received | 2014-09-16 |
| Device Manufacturer Date | 2012-12-03 |
| Date Added to Maude | 2014-10-08 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBMARINE RAPIDO |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, DUAL-BALLOON |
| Product Code | NVM |
| Date Received | 2014-09-30 |
| Returned To Mfg | 2014-08-26 |
| Catalog Number | SBR070030135 |
| Lot Number | 1D032139 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVATEC SPA |
| Manufacturer Address | VIA MARTIRI DELLA LIBERTA, 7 RONCADELLE 25030 IT 25030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |