MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER; BALLOON CATHETER

Model Number	60109-5560
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Peripheral Vascular Disease (2002)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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balloon did not separate from the device at the time of balloon rupture, but the event occurred as the device was being withdrawn through the sheath.This root cause is also supported by the inspection of the balloon segments and the returned sheaths.The review of the manufacturing lhr and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.
Event or Problem Description
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.

• Brand Name: LITHOPLASTY PERIPHERAL BALLOON DILATATION CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 48501 warm springs blvd.; suite 108; fremont CA 94539
• MDR Report Key: 8134174
• Report Number: 3010940016-2018-00001
• Device Sequence Number: 2363740
• Product Code: PPN
• UDI-Device Identifier: M732LPBC5560DX1
• UDI-Public: M732LPBC5560DX1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: 60109-5560
• Device Catalogue Number: M732LPBC5560DX1
• Device Lot Number: P171220C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 12/05/2018
• 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: 68 YR
• Patient Weight: 75