MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5IVL7060
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All parts of the ivl balloon catheter were received at swmi for investigation.The distal portion of the ivl balloon catheter was found to be separated from the device.The separated distal end of the ivl balloon catheter measured approximately 13mm.Minor scuffs and scratches were noted in the vicinity of the rupture and between the proximal marker band and an emitter.All parts of the ivl balloon catheter were successfully removed from the patient.The reported failure was confirmed.Based on the investigation observations and additional information received from the reporting party, the balloon loss of pressure and subsequent detachment of balloon components could possibly be attributed to the patient calcium.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lots does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.
Event or Problem Description
A shockwave m5 peripheral lithotripsy (ivl) device was successfully used to treat a lesion, using bilateral kissing balloon technique in the bilateral iliacs; two (2) m5 ivl devices were used, one in each iliac.A balloon rupture occurred with the ivl balloon in the left iliac after delivering 92 pulses at 4 atm.Upon removal of the ivl catheter, the physician noticed the marker band and part of the balloon was still on the wire.A surgical cut down into the left groin was performed to facilitate insertion of a 12 f sheath, and snaring was performed to retrieve the wire and detached component of the ivl catheter.The remaining portion of the balloon was removed successfully.Covered stents were placed bilaterally without incident.The patient was an inpatient and had to be intubated.Post procedure the left groin needed to be surgically closed.Patient was discharged on (b)(6) 2021.The physician believes that sharp calcium may have contributed to the balloon loss of pressure and subsequent detachment of the ivl balloon catheter upon withdrawal from the patient.It is not known which ivl catheter ruptured.So, both lot numbers are included in this report (p210226c and p201211e).

• Brand Name: SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 12708421
• Report Number: 3015053858-2021-00023
• Device Sequence Number: 3984058
• Product Code: PPN
• UDI-Device Identifier: 00195451000195
• UDI-Public: (01)00195451000195(17)230228(10)P210226C
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: M5IVL7060
• Device Catalogue Number: M5IVL7060
• Device Lot Number: P210226C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.35 GLIDEWIRE 300CM (TERUMO); 0.35 ROSEN WIRE GUIDE 260CM (COOK MEDICAL); 0.350 BENTSON GLIDEWIRE 180CM (BOSTON SCIENTIFIC); 4FRX 65CM ANGLE GLIDE CATH; 7FRX23CM SHEATH BRITE TIP (CARDINAL); 7FRX45CM SHEATH BRITE TIP (CARDINAL); EN SNARE 6FRX 100CM (MERIT MEDICAL); SHOCKWAVE IVL CATHETER, M5 7.0X60MM, P201211E; V-14 CONTROL WIRE 0.14X300CM (BOSTON SCIENTIFIC)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR