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

Model Number	C2IVL3512
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.The reported separation was confirmed.Based on the investigation performed, the balloon may have been likely got stuck within the sheath and possibly excess force was used to try to remove it.This resulted in the separation of the distal shaft and inner lumen.The cause of the balloon being stuck in the sheath could not be definitively determined.A review of the manufacturing and test documentation for the subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.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.
Event or Problem Description
Iit was reported that a patient underwent a percutaneous coronary intervention (pci) and percutaneous transluminal coronary angioplasty (ptca) procedures to treat a concentric de novo lesion located in the left anterior descending (lad) artery.Prior to the start of procedure, the lesion was pre-dilated using a non-compliant (nc) balloon.Then a shockwave c2 coronary intravascular lithotripsy (ivl) catheter was advanced towards the target vessel and successfully delivered 80 pulses to the target lesion.When the physician attempted to withdraw the ivl from the patient's anatomy, resistance was encountered.As the ivl was being withdrawn, the balloon was caught in the teleflex guideliner and it subsequently broke.The initial break occurred at the distal tip of the guideliner, but the complete separation was reported to be inside but could not be definitively determined as the staff was not using live imaging upon pulling out the catheter.The physician used spectre¿ guidewire to successfully retrieve the fragment(s) from the guideliner while it was still inside the patient.Post ivl procedure, the lesion was expanded with a synergy drug-eluting stent (des).There were no patient clinical sequelae reported.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (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
• MDR Report Key: 16751755
• Report Number: 3015053858-2023-00017
• Device Sequence Number: 19677883
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)240731(10)A220719C
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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: 07/31/2024
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A220719C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: SPECTRE¿ GUIDEWIRE - TELEFLEX - TELEFLEX.; TELEFLEX GUIDELINER - TELEFLEX.
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic