MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5IVL7060
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave m5 peripheral lithotripsy (ivl) device was successfully used to treat a lesion, using bilateral kissing balloon technique in the iliac arteries.A balloon rupture occurred after delivering 150 pulses at 4 atm.It was noted the balloon rupture occurred after taking the shockwave catheter to a nominal pressure of 6 atm.Upon attempts to withdraw the device, the balloon got stuck in the introducer sheath and a portion of the balloon catheter detached and remained inside the artery and surrounding tissue.After multiple attempts to remove the device, the physician decided the best option for care was to perform a cut down on the patient to retrieve the remaining portion of the balloon.The remaining portion of the balloon was removed successfully.Based on the last available information, the patient is doing well.As of the date of this report, there have been no additional sequelae reported.
Additional Manufacturer Narrative
The ivl catheter, as well as the introducer sheath (not manufactured by shockwave), were returned for evaluation.Based on the evaluation of the returned device, there was evidence of complete separation of the balloon from the catheter.The sheath was inspected, and the distal tip was found to be folded inwards.The inner member was separated from the balloon.All other components of the ivl balloon catheter were inspected and were observed to be intact.The reporting party confirmed that all pieces of the catheter were removed from the patient's body and all pieces were examined before shipping to shockwave.The balloon loss of pressure is likely due to the balloon interaction with patient calcium.The difficulties to remove the catheter and subsequent detachment of components cannot be definitively determined; however, based on the physician's opinion, the difficulties to remove the device can be attributed to the introducer sheath.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lots does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.

• Brand Name: SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 12411346
• Report Number: 3015053858-2021-00017
• Device Sequence Number: 4191136
• Product Code: PPN
• UDI-Device Identifier: M732M5IVL70600
• UDI-Public: M732M5IVL70600
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: M5IVL7060
• Device Catalogue Number: M5IVL7060
• Device Lot Number: P200713D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7X30 COOK SHEATH; BMW WIRE-180CM; SHOCKWAVE M5 (MODEL # M5IVL7060 LOT # P210127P)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 93