MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-05 for LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER 60109-5560 M732LPBC5560DX1 manufactured by Shockwave Medical, Inc..
[129594093]
Based on observations from reviewing of the case details, it is concluded that the balloon was punctured, when the device was repositioned prior to the balloon being fully deflated. The distal balloon did not separate from the device at the time of balloon rupture, but the event occurred as the device was being withdrawn through the sheath. This root cause is also supported by the inspection of the balloon segments and the returned sheaths. The review of the manufacturing lhr and quality inspection records for the balloon component and catheter processing provides assurance that the root cause was not swmi device design / manufacturing related. Conclusion: based on the investigation, it is concluded that the balloon rupture was due to the sharp calcification and incomplete deflation of balloon during reposition. The balloon separation was due to the interaction force between the balloon and the sheath. The cause of this event is not swmi design/ manufacturing related. Note: the mdr was initially submitted on may 8, 2018 and acknowledgement email was received by shockwave medical. However, additional information was required prior to posting. The mdr is now being refiled with requested information per helpdesk recommendation.
Patient Sequence No: 1, Text Type: N, H10
[129594094]
A 6x60mm catheter was used to treat the mid-sfa. After three cycles of treatment, there was an attempt to inflate the balloon but no pressure held. The catheter was removed. Upon evaluation of the catheter, it was noticed that a portion of the balloon had separated from the catheter. Under fluoro, it was identified as being retained on the guidewire. The balloon was then captured using a snare and removed from the body in a single piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010940016-2018-00001 |
| MDR Report Key | 8134174 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-05 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-12-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN KIRTLAND |
| Manufacturer Street | 48501 WARM SPRINGS BLVD SUITE 108 |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5102794262 |
| Manufacturer G1 | SHOCKWAVE MEDICAL INC. |
| Manufacturer Street | 48501 WARM SPRINGS BLVD SUITE 108 |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94539 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2018-12-05 |
| Returned To Mfg | 2018-04-16 |
| Model Number | 60109-5560 |
| Catalog Number | M732LPBC5560DX1 |
| Lot Number | P171220C |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHOCKWAVE MEDICAL, INC. |
| Manufacturer Address | 48501 WARM SPRINGS BLVD. SUITE 108 FREMONT CA 94539 US 94539 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-05 |