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

Model Number	2332-8040
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Atherosclerosis (1728)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.This information was not available from the facility.The angiosculpt device was unable to deflate.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.Patient information regarding relevant tests/laboratory data, or medical history is unknown.This information was not available from the facility.The angiosculpt device returned for evaluation.Visual examination found a distal bond peel with three leaflets lifted, but remained intact to the device.The balloon appeared to be deflated and the transition tubing was wrinkled.During functional testing, the balloon was unable to inflate even after multiple attempts.Under microscopic inspection, the inner member inside the proximal balloon was stretched and accordion.A needle was inserted at the proximal end of the balloon to inflate by using an adapter, connected to a syringe.The balloon was pressurized to 2 atm and a pinhole leak was observed at the distal end and was able to deflate.Due to the nature of the returned device, the balloon deflation issue could not be determined.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
An 8 x 40 mm angiosculpt was used to treat the avf.The balloon was inflated to 12 atm and was unable to deflate.The tech pulled negative on a 20 cc syringe with no affect on the balloon.The 20 cc syringe was disconnected and replaced with a 60 cc syringe, with only a partial balloon deflation noted.The physician used a needle to puncture several holes through the patient to deflate the balloon, which resulted in partial deflation.However, with force the angiosculpt was pulled through a 7f introducer sheath and was able to be removed.No injuries were sustained by the patient.

• 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: 7671929
• Report Number: 3005462046-2018-00014
• Device Sequence Number: 751834
• Product Code: PNO
• UDI-Device Identifier: 00813132022204
• UDI-Public: 00813132022204
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• 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): 06/13/2018
• Report Date (Section F): 01/01/2005

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: No Information
• Device Expiration Date: 06/01/2020
• Device Model Number: 2332-8040
• Device Catalogue Number: 2332-8040
• Device Lot Number: G17050055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005