MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2249-60200
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During use, the angiosculpt device was inflated above rbp and during withdrawal, the device separated in two pieces.Additional intervention was required to remove the distal portion of the device, resulting in a prolonged procedure.No piece of the angiosculpt device was retained in the patient.The distal portion of the angiosculpt device was returned intact to a 0.014" guide wire.This includes the distal tip, distal bond, balloon, scoring element, two marker bands, inner member, and intermediate bond.All device components proximal to the intermediate bond were not returned; which includes the transition tubing, proximal bond, proximal shaft, strain relief, and hub/luer.Visual inspection found a bent distal tip and an accordioned balloon that detached from the intermediate bond.Additionally, a longitudinal tear was noted on the proximal portion of the balloon and the scoring element was partially detached at the intermediate bond.Based on the complaint details, the angiosculpt device was used off-label.The balloon was inflated above rbp and ruptured.The ifu warns to not exceed the rated burst pressure as indicated on the product label.For device removal, some degree of force was applied that likely caused or contributed to the device separation.The ifu warns if resistance is met during manipulation, determine the cause of the resistance before proceeding.In addition, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was inserted in isr of the mid sfa with no issues.Then, the balloon was inflated above rbp and the balloon ruptured.Upon removal, resistance was noted and the balloon portion got caught in the introducer sheath.In order to remove from the patient, some degree of force was applied, resulting in a device separation.The distal portion of the balloon was left in the patient; however it was able to be removed by performing a cut down approach.No piece of the angiosculpt device was retained in the patient.The procedure was completed with a laser device.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 10752683
• Report Number: 3005462046-2020-00043
• Device Sequence Number: 1061414
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• 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): 09/30/2020

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: 04/22/2022
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G20040023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2020
• 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: COOK: 0.014" APPROACH HYDRO ST GUIDE WIRE; COOK: 6F FLEXOR ANSEL 45CM INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84