MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-30 for LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER 60109-7060 M732LPBC7060DX1 manufactured by Shockwave Medical, Inc..
[129468262]
From the procedural description and interview with the swmi representative, who was present at the case, the device performed as intended and during the initial 90 pulses ivl therapy the catheter remained intact and undamaged. The investigation of the returned device and guidewire concluded that the distal end of the catheter and balloon were trapped by the stent during removal and caused the distal end of the balloon to tear under the tensile load. The returned device analysis, procedural details gathered during the investigation, and feedback from personnel present at the case suggests that the primary cause of the malfunction was due to misuse of the device, specifically as listed below: the ifu includes a "caution" statement that "lithoplasty catheter once pulled out of the body should not be reinserted for additional inflation or lithoplasty treatments. Balloon can be damaged in the process. " the ivl catheter was removed and reinserted back in the body against the caution provided in the ifu. Per the "contraindications for use" in the ifu, the device is not intended for treatment of in-stent restenosis. The discretionary call was made by the physician to treat in stent restenosis during this event. The lithotripsy treatment balloon pressure per ifu should be performed at 4 atm. The lithotripsy treatment was provided at burst pressure of 10 atm. The 10 atm treatment pressure is higher than the 4 atm lithotripsy treatment balloon pressure per the ifu. A review of lot history record demonstrates that the ivl catheter met acceptance criteria prior to release to distribution. There is no evidence to suggest that the device was defective or did not meet its specification upon initial release from manufacturing. Upon completion of therapy, the final angiography showed a good distal runoff strongly indicating that there was no embolic event. The patient had no additional complications three days post event. The physician plans to continue to follow the patient and has stated that the treatment is complete.
Patient Sequence No: 1, Text Type: N, H10
[129468263]
During a peripheral intravascular lithotripsy (ivl) procedure, an ivl catheter experienced a loss of pressure. The catheter was initially difficult to remove on its own, requiring that both the ivl catheter and guidewire be removed together. Upon evaluation of the catheter, it was noticed that the catheter was fused to the guidewire and a portion of the balloon along with the distal bond/tip had separated from the catheter. All other catheter components appeared to be present. The distal portion of the catheter although separated from the main shaft, was retained on the guidewire and was able to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010940016-2018-00002 |
| MDR Report Key | 8120437 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2018-11-30 |
| 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 | 5106249076 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2018-11-30 |
| Returned To Mfg | 2018-11-05 |
| Model Number | 60109-7060 |
| Catalog Number | M732LPBC7060DX1 |
| Lot Number | P180619B |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-30 |