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

Model Number	2237-60100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patent's dob or age at time of event, weight, ethnicity, and race are unknown.Attempts to obtain the information has not been successful.During removal, patient injury occurred.Additional intervention was required, resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data or medical history are unknown.Attempts to obtain the information has not been successful.Foreign- (b)(6).The angiosculpt device is expected to return.Device evaluation will be performed upon arrival and a supplemental mdr to follow.
Event or Problem Description
The user experienced difficulties extracting the balloon.During removal, one of the external wires ruptured against the skin and required surgical removal within 24hrs.
Additional Manufacturer Narrative
Block d10/g4: the angiosculpt scoring element component was returned for evaluation on 11/18/2020.Block h3: visual examination found 2 scoring element struts detached from the inner ring, but remained intact on the opposite end.The rest of the device was not returned, which includes the following components: distal tip, distal bond, balloon, 2 marker bands, intermediate bond, transition tubing, proximal bond, shaft, strain relief, hub/luer.
Event or Problem Description
No difficulties with advancement.The balloon was inflated to 10 atm, 3-4 times with no issues.Despite a long deflation time, there was difficulty inserting the balloon into the introducer sheath, imposing a back and forth maneuver with the deflated balloon.After many tries, a decision was made to extract the introducer sheath with the balloon partially inserted.During this time, resistance was noted in the contralateral axe due to the stents likely blocking the scoring element from removal.The introducer sheath and device were extracted as a unit, but one of the scoring element was absent.Under fluoroscopy, visualization of the scoring element was observed in the arterial axe.Immediate surgical intervention was performed to remove the detached scoring element.Patient status today remains unknown.
Additional Manufacturer Narrative
Block b5: included additional information received from the distributor.Block d11: included introducer sheath manufacturer and brand name.Size remains unknown.Block h6: the angiosculpt device was not returned.A subsequent report will be filed if the device is returned or if new information becomes available.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.In addition, based on the complaint details provided, the angiosculpt device got caught on an existing stent.It is possible that this may have caused or contributed to the detachment of the scoring element.

• 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: 10486026
• Report Number: 3005462046-2020-00023
• Device Sequence Number: 4060257
• Product Code: PNO
• UDI-Device Identifier: 00813132022846
• UDI-Public: 00813132022846
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K112182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020
• 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: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 2237-60100
• Device Catalogue Number: 2237-60100
• Device Lot Number: G20040008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 08/06/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/30/2020; 12/08/2020
• 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: TERUMO: DESTINATION INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005