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

Model Number 2200-2515

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

During the returned device evaluation, a distal bond peel was observed, but remained intact to the device.Recurrence of this malfunction could result in an embolism, myocardial ischemia or infarction, or 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 was returned for evaluation.Visual inspection found a distal bond peel with five leaflets lifted, but remained intact to the device.In addition, the intermediate shaft was flattened and stretched, which measured approximately 14 cm over the specification.No defect was noted on the hypotube.Based on the lab analysis, it is likely excessive exertion of force was applied by the user, resulting in the damage observed on the device.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

During use in patient, the angiosculpt device was defective.The hypotube was stretched out and became floppy.The procedure was completed with a new device and no patient injury reported.During the returned device evaluation on 10/10/2019, a distal bond peel was observed.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9272687
• MDR Text Key: 185502912
• Report Number: 3005462046-2019-00015
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021184
• UDI-Public: 00813132021184
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: G19050020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 59