MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	2.5 X 12MM
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with a 75% occluded lad #6 with a calcification score 4 was treated via percutaneous coronary intervention (pci).Using a 7f guideplus guide, predilation of the target lesion was performed using a 2.0 mm non-compliant balloon (nc) followed by oct.A 2.5x12mm ivl catheter inserted into the patient and advanced up to the target lesion and would not cross.The ivl catheter was removed, and predilitation was again performed using the 2.0 mm nc balloon at 12 atm.The ivl catheter was re-inserted into the patient a 2nd time, and the ivl catheter still would not cross the lesion.The ivl catheter was removed, and the lesion was predilated 2 additional instances with a 2.5 mm nc balloon, each time the ivl catheter was removed from the patient and re-inserted into the patient, still unsuccessful crossing the lesion.The guideplus was pushed again, and the ivl still would not cross.The ivl catheter was removed from the patient, and the guideplus guide was replaced with a 6f ez guide.The ivl catheter was again re-inserted into the patient for the 5th time, at which time the ivl catheter shaft was observed to be deformed (shrank) around the exit port.The ivl catheter was removed from the patient and exchanged with another 2.5mm ivl catheter.There was no patient harm associated with this event.The device was returned and has been evaluated by the manufacturer (mfr ref: (b)(4)).Based on the information reported, a single ivl catheter was used for multiple re-insertions into the patient which is off label per the ivl catheter instructions for use.The catheter is intended for single (one) time use only and not to be reused per the ivl device precautions.Upon exchange of the 1st damaged ivl catheter, the 6f/25cm ez guide extension catheter was changed to a 6f/40cm ez guide extension catheter, and pre-dilation of the lesion was again performed using a 2.5 mm nc balloon.The 2nd ivl catheter (2.5mm) was inserted into the patient and attempted to be delivered but could not cross.Physician decided not to treat the lesion at lad #6 distal and treat proximal side of the lesion (lad #6 proximal).The guide extension reached the #6 proximal lad lesion, the ivl catheter had reached the guide extension's distal tip.While maintaining the position of the ivl catheter, the physician attempted to pull-back the guide extension to perform ivl treatment, but the guide extension could not be pulled back.The physician reconfirmed the position of guide extension by attempting to pull-back the guide extension catheter again, at which time the guide extension catheter was observed to have broken-off at shaft.The ivl catheter was used to retrieve the piece of the broken guide extension from the patient by inflating the ivl balloon, successfully removing the broken piece from the patient.The physician elected to not perform ivl, and a cutting balloon was alternatively used followed by stenting to complete the procedure.There was no damage to the 2nd ivl catheter; the ivl catheter was not available for evaluation as it was discarded at the hospital (mfr ref: (b)(4)).A separate report will be submitted for the 2nd ivl catheter (mfr ref: 3015053858-2023-00054).
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported failure of unable to cross the lesion could not be confirmed but the deformed shaft was confirmed.Based on the reported information, the multiple insertions and removal of the device have likely to the damage to the shaft.Additionally, during investigation, it was found that there was a metal foreign body on the shaft (possibly a broken piece of the guide extension).The metal foreign body was found to be dented and attached to the catheter shaft proximal to the balloon.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Additional Manufacturer Narrative
The cause of the broken shaft was found to be related to user error.Per the ifu for the shockwave c2 ivl catheter, it is stated that: 'ivl catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy treatments.Balloon can be damaged in the process.' based on the information reported, a single ivl catheter was used for multiple re-insertions into the patient which is off label per the ivl catheter instructions for use.The catheter is intended for single (one) time use only and not to be reused per the ivl device precautions.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 18323374
• Report Number: 3015053858-2023-00077
• Device Sequence Number: 15343185
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)250531(10)10A230531A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 05/31/2025
• Device Model Number: 2.5 X 12MM
• Device Catalogue Number: C2IVL2512
• Device Lot Number: 10A230531A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 05/05/2025
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 12/22/2023; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F EASYGUIDE EXTENSION CATHETER.; 7F GUIDEPLUS¿ (GUIDE EXTENSION CATHETER).; NON-COMPLIANT (NC) BALLOON CATHETERS.; OPTICAL COHÉRENCE TOMOGRAPHY (OCT).; STENT.
• Patient Sex: Unknown