MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3015
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's ethnicity and race are unknown.This information was not available from the facility.During the procedure, the shaft ruptured, and the balloon was unable to fully deflate prior to removal.Recurrence of the malfunction could result in vessel obstruction potentially requiring further intervention or prolonged procedure.Visual inspection found the balloon partially inflated.In addition, a tear was observed on distal shaft, opposite side of the lacerated rx port.During functional testing, the device was pressurized at less than 2 atm, and a leak was observed on the opposite side of the rx port.Based on the lab analysis, the root cause of the shaft burst/rupture could not be determined.A probable root cause may be due to material selection, or process design.
Event or Problem Description
The angiosculpt device was used with a guide wire and a buddy wire to treat a moderately calcified and moderately tortuous mid cx into the om artery.During the third inflation when trying to go above 16 atm, the shaft ruptured and the balloon was unable to fully deflate.The device was removed from the guide wire with no issues.An ivus was performed immediately, and confirmed no coronary dissection occurred.The procedure was competed with a standard balloon, and the patient was asymptomatic throughout the entire event.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 10785324
• Report Number: 3005462046-2020-00046
• Device Sequence Number: 19560285
• Product Code: NWX
• UDI-Device Identifier: 00813132021214
• UDI-Public: 00813132021214
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: 04/16/2023
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G20040019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• 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: ASAHI: 0.014" FIELDER GUIDE WIRE; MEDTRONIC: 6F EBU GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 105