MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3515
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob and weight are unknown.This information was not available from the facility.Foreign: (b)(6).The angiosculpt has not been returned by the facility, thus no returned product investigation was performed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
The angiosculpt device was used in a severely calcified proximal rca.Prior to the angiosculpt, a rotablation device was used.The angiosculpt was inflated multiple times and during the 4th inflation at 16 atm for 12 seconds, the balloon burst.Upon removal, the device was caught in the patient¿s anatomy and unable to be removed.With much force applied, a portion of the balloon separated radially in the patient.The patient was in stable condition, but was transferred by helicopter to another hospital for bypass.This adverse event and product problem is being submitted because the balloon ruptured radially and required surgical intervention (bypass).
Event or Problem Description
Based on the device evaluation and additional information received, the device separated at the intermediate shaft and not a radial balloon separation as reported in the initial mdr.This adverse event and product problem is being submitted because the balloon ruptured and the intermediate shaft separated requiring surgical intervention (bypass).
Additional Manufacturer Narrative
Block h3: the angiosculpt catheter was returned with just the proximal portion.This includes hypotube, hypotube bond, a portion of the intermediate shaft, luer, and strain relief.Visual inspection found no damage to the proximal portion and measures approximately 117 cm.The distal portion of the catheter was not returned.This includes the distal tip, distal bond, balloon, scoring element, intermediate bond, transition tubing, rx port, proximal bond, and distal shaft.Overall catheter measurement is 137 cm which confirms that approximately 20 cm separated from the catheter.The reported balloon rupture could not be confirmed since the distal portion separated and not returned.Block h6: based on the device evaluation and complaint details, the catheter got caught on the severely calcified lesion and the degree of force applied by the user likely resulted in the shaft separation.Per the ifu, retained device components is listed as a possible adverse effects of the procedure.Additionally, component code #4721 (rod/shaft) was added to document the shaft separation.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 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: 15020128
• Report Number: 3005462046-2022-00029
• Device Sequence Number: 17856859
• Product Code: NWX
• UDI-Device Identifier: 00813132021245
• UDI-Public: 00813132021245
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P050018
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 01/31/2025
• Device Model Number: 2200-3515
• Device Catalogue Number: 2200-3515
• Device Lot Number: G22010049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: ABBOTT: WHISPER ES GUIDEWIRE, SIZE UNK; MEDTRONIC: 7F AL1 GUIDE CATHETER; TERUMO: 7F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White