MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC SHOCKWAVE M5 IVL CATHETER; BALLOON CATHETER

Model Number	FG62868-5060
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Peripheral Vascular Disease (2002)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main catheter body, proximal end of the balloon, and the marker band were returned to shockwave medical for investigation.However, the distal part of the balloon which separated from the catheter during the procedure was not returned.The separation of the distal portion of the catheter was confirmed.The cause of the device separation indicates that the catheter was subjected to a force beyond normal usage.Review of the device manufacturing and test records indicate that the device lot met all of shockwave's acceptance criteria prior to being released for distribution.It was reported that the patient lesion was heavily calcified (corral reef), which could be considered a contributory cause.Based on the physical inspection of the device, a review of manufacturing documentation and information provided by the physician, shockwave medical is of the opinion that coral reef calcium likely led to the balloon loss of pressure and kinked wire which made withdrawal difficult.Combined with the possible mushrooming of the ruptured balloon when being withdrawn into the sheath and application of excessive force probably led to distal catheter separation.
Event or Problem Description
The shockwave complaints team reached out to the operating physician who provided the following information about the case: the patient was approximately in their late 60s/early 70s with a history of hypertension and likely a smoker.The patient indicated a high degree of calcification (coral reef kind) and hence shockwave ivl therapy was chosen.Ivl therapy was provided to the femoral artery per the ifu at 4atm when he noticed that the ivl device lost pressure.At some point in the procedure the grand slam guidewire kinked, making it difficult to withdraw and the physician had to retrieve both the wire and ivl catheter together.The physician confirmed that the correct sheath size was used, however some resistance was felt during withdrawal and additional force had to be exerted to withdraw the device.The intent was to continue the procedure further with a non-ivl device when the marker band was noticed under fluoroscopy.The withdrawn ivl catheter was inspected and it was noticed that about half of the distal balloon portion was missing.A snare method was used to remove the separated pieces and the physician confirmed that nothing was left behind in the patient.The final patient outcome was good and no patient injury was noted or any additional hospitalization was required.The physician is of the opinion that coral reef calcium likely led to the balloon loss of pressure and kinked wire which made withdrawal difficult.Combined with the possible mushrooming of the ruptured balloon when being withdrawn into the sheath and application of excessive force probably led to distal catheter separation.

• Brand Name: SHOCKWAVE M5 IVL CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; santa clara, ca
• MDR Report Key: 10330088
• Report Number: 3015053858-2020-00009
• Device Sequence Number: 3162797
• Product Code: PPN
• UDI-Device Identifier: M732LPBC5060DX1
• UDI-Public: M732LPBC5060DX1
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: FG62868-5060
• Device Catalogue Number: M5IVL5060
• Device Lot Number: P191031J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/27/2020
• 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