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

Model Number	C2IVL3012
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this complaint was returned to shockwave for investigation.The reported complaint of unable to deflate the balloon and remove the catheter could not be definitively confirmed.Based on the additional information received, the physician believes that the ivl balloon was caught on the patient's calcium and all components of the catheter were successfully removed from the patient.A review of the lot history record (lhr) indicates that the device met all inspection criteria prior to shipping.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.Shockwave medical 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
A shockwave c2 coronary intravascular lithotripsy (ivl) balloon was used in a patient who underwent a procedure to treat a chronic total occlusion (cto) at the right coronary artery (rca).Access was obtained via femoral artery.After 40 pulses were delivered, the physician deflated the balloon to pull it out however, the balloon would not deflate and could not be removed.The physician cut off the hub of the ivl catheter and used a guide extension to help remove the catheter.The balloon was able to be withdrawn as soon as the guide extension added additional support and changed the angle of the balloon.The ivl balloon came out intact, minus the hub that was cut off to advance the guide extension over the balloon.Additionally, the physician believes the balloon got snagged on calcium.Post ivl, rotational atherectomy was performed and was followed with drug eluting stent (des) placement.There was no patient injury reported.No additional information was provided.

• 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: 13980799
• Report Number: 3015053858-2022-00021
• Device Sequence Number: 12260789
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(10)A211130J
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/14/2022

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: 11/30/2023
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A211130J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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: DRUG ELUTING STENT (MEDTRONIC); GUIDE EXTENSION (UNKNOWN MANUFACTURER); ROTATIONAL ATHERECTOMY INSTRUMENT (UNK MFR)
• Patient Sex: Unknown