MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT OTW PTA; CATHETER, PTA, CUTTING/SCORING

Model Number	2092-5040
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign (b)(6).The angiosculpt device was returned for evaluation.Preliminary investigation confirms a balloon radial tear.Further investigation is still on-going, thus a supplemental report will be filed upon completion.
Event or Problem Description
The angiosculpt device was used to treat a moderately calcified mid sfa.During inflation at 14 atm for 10 seconds, the balloon ruptured.Upon removal of the balloon, the balloon got stuck in the sheath and an 8fr sheath was inserted into the distal sfa and was able to remove the catheter.A stent was placed for hemostasis.The procedure was completed with the suspect device.During the returned product evaluation, a balloon radial tear was confirmed.This adverse event and product problem is being submitted because the balloon ruptured radially and required additional intervention to complete the procedure.
Additional Manufacturer Narrative
Block b5/g3: additional information received on 11/05/2021.Block h3: the angiosculpt device was returned for evaluation in two pieces.The shaft was separated at the transition tubing, proximal to the intermediate bond.Visual inspection found a damaged distal tip and a balloon radial tear with the proximal portion of the balloon missing.The scoring element was found misaligned and a scratch on the luer was observed.Note: the shaft separation did not occur during use.The physician intentionally cut the angiosculpt outside of the patient to remove it from the sheath.Block h6: per the ifu, retained device components is listed as a possible adverse effects of the procedure.
Event or Problem Description
A stent placement was required to treat the hemostasis that resulted with the use of the angiosculpt device.The patient was discharged as scheduled without issues.No portion of the device remained in the patient.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, 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
• MDR Report Key: 12740890
• Report Number: 3005462046-2021-00062
• Device Sequence Number: 4099887
• Product Code: PNO
• UDI-Device Identifier: 00813132021412
• UDI-Public: 00813132021412
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: 2092-5040
• Device Catalogue Number: 2092-5040
• Device Lot Number: G21030008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI: CRUISE GUIDEWIRE, SIZE UNK; MEDIKIT: PARENT PLUS SHEATH/GUIDE SIZE UNK; ASAHI: CRUISE GUIDEWIRE, SIZE UNK; MEDIKIT: PARENT PLUS SHEATH/GUIDE SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown