MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER; BALLOON CATHETER

Model Number	FG62868-7060
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Peripheral Vascular Disease (2002)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned to the manufacturer's facility and was physically inspected.The distal portion of the balloon was confirmed to be missing.The rest of the catheter components were found to be intact.A review of the manufacturing and test documentation does not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.Per the information provided by the shockwave rep, the physician was pleased with the outcome and was not overly concerned with the device separation.The physician felt that this is not a unique risk to shockwave and indicated that this could have happened with any therapeutic device in an extremely stenotic artery.The patient had no distal pulse at the beginning of the procedure, but had bounding pulse at the completion of the procedure.The vessel appeared to have opened completely post-ivl.Based on the physical inspection of the device, a review of manufacturing documentation and the physician's narrative, it is determined that the separation of material is attributed to the procedural risk in an extremely stenotic artery.
Event or Problem Description
Based on information provided, the patient had distal occlusive disease, calcified aorta and calcified bilateral iliac.Endarterectomy was performed on one peripheral section.The right iliac was treated with swmi 7.0 ivl device using a 7fr, 23 cm sheath.150 pulses were delivered at 4 atm, post-ivl dilation to 6 atm and then to 8atm when the balloon burst.When the ivl catheter was removed, the distal portion of the balloon was missing.A self-expanding stent was placed and the physician believes that the stent had pinned the separated balloon portion against the iliac walls.The stent placement was pre-planned and the physician did not consider the stent placement as additional intervention.The patient had no distal pulse at the beginning of the procedure, but had bounding pulse at the completion of the procedure.The vessel appeared to have opened completely post-ivl.Physician was pleased with the outcome and was not overly concerned with the device separation.The physician felt that this is not a unique risk to shockwave and indicated that this could have happened with any therapeutic device in an extremely stenotic artery.

• Brand Name: PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 9565959
• Report Number: 3015053858-2020-00001
• Device Sequence Number: 2196829
• Product Code: PPN
• UDI-Device Identifier: M732LPBC7060DX1
• UDI-Public: M732LPBC7060DX1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: FG62868-7060
• Device Lot Number: P191009D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR