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

Model Number	2076-5040
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's gender, dob or age at time of event, weight, ethnicity, and race are unknown.This information was not available from the facility.During removal, the angiosculpt device got stuck on the guide wire and removed as a unit.The same guide wire was reinserted to complete the procedure, thus resulting in a prolonged procedure.No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.Report source: foreign- (b)(6).The angiosculpt device has not been returned, thus no returned product investigation was performed.Per the ifu, if resistance is met during manipulation, determine the cause of the resistance before proceeding.In addition, the health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter code: (b)(4).
Event or Problem Description
It was reported that during a peripheral procedure, the angiosculpt balloon was inserted over an 0.014" guide wire and inflated at nominal pressure dilating the lesion 5 times.In order to place a stent, guide wire was exchanged from an 0.014" to an 0.018".However during removal of the 0.014" guide wire, resistance was noted, but able to be removed alone.Then, during insertion of the angiosculpt balloon over the 0.018" guide wire, strong resistance was encountered at the hub and was unable to be inserted, thus were removed as a unit.After removal, the 0.018" guide wire was re-inserted and the procedure was completed with a stent.No patient injury reported.
Additional Manufacturer Narrative
Block d9/g3: the angiosculpt device was returned for evaluation.Block h3: visual examination found a blood-stained distal shaft and a damaged (accordioned) inner member within the hub.During functional testing, a 0.018" laboratory guide wire was inserted through the distal tip and advanced through the catheter, but the guide wire was met with increasing resistance as it approached the middle of the proximal shaft where dried blood was present and could no longer advance.The guide wire was removed and attempted to back-load through the guide wire port at the hub.The guide wire was inserted past the accordioned area in the hub with minor resistance, however, increasing resistance was met around the middle of the proximal shaft and could no longer advance.Block h6: added codes 4721 (rod/shaft), 2199 (no health consequences or impact), 10 (testing of actual/suspected device), 3243 (stress problem identified), and 4307 (cause traced to component failure).

• 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: 11864171
• Report Number: 3005462046-2021-00027
• Device Sequence Number: 3172547
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G18100008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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: ASAHI: 0.018" TREASURE FLOPPY GUIDE WIRE; TERUMO: 6F DESTINATION SHEATH/GUIDE; ASAHI: 0.018" TREASURE FLOPPY GUIDE WIRE; TERUMO: 6F DESTINATION SHEATH/GUIDE
• Outcome Attributed to Adverse Event: Hospitalization