MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-26 for IVL PERIPHERAL BALLOON DILATATION CATHETER 60109-4060 M732LPBC4060DX1 manufactured by Shockwave Medical, Inc..
[139996555]
The lot history record for lot p180321b was reviewed. The lot satisfied acceptance criteria prior to release for distribution. The manufacturing records indicate that the lot was built to approved procedures and met in process inspection criteria. Conclusion: the devices were confirmed to be functional as intended and successfully provided ivl therapy prior to the complaint event. Based on the investigation, the device was damaged through accidental customer misuse. There was no patient harm or adverse outcome. Patient was discharged and is doing well. The instructions for use, lbl 61932 rev a, were reviewed and confirmed to include the following relevant warnings: do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury. It is determined that the cause of the complaint is not attributed to swmi design or manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[139996556]
A 4. 0mm x 60mm and 7. 0mm x 60mm shockwave ivl catheters were introduced side by side in a heavily calcified and diseased aorta. The physician was using a technique called "kissing balloons". Their treatment plan was to pulse each balloon separately in an effort to modify an eccentric calcified lesion. After successfully delivering ivl therapy to the lesion and achieving positive results the physician decided to pull back the 4mm balloon without deflating the balloons prior to pullback, so the balloons were pinned to each other and to the interior of the aorta. The balloons experienced tensile force sufficient to cause the balloon material to tear. In addition, the catheter inner member was damaged and broke into 2 pieces. Immediately upon detecting this use error the physician proceeded to remedy the situation by snaring and removing the catheter pieces. The physician was confident that all catheter components including the distal end of the balloon were retrieved. Follow up angiograms showed excellent flow and successful treatment. There was no patient harm or adverse outcome. Patient was discharged and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010940016-2019-00001 |
| MDR Report Key | 8454436 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-26 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2019-03-26 |
| 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 | IVL PERIPHERAL BALLOON DILATATION CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-11 |
| Model Number | 60109-4060 |
| Catalog Number | M732LPBC4060DX1 |
| Lot Number | P180321B |
| 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 94539 US 94539 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |