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

Model Number	2249-60200
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
From the arm access, the physician¿s target lesion was the sfa, but was unable to reach the sfa; therefore, the balloon was inflated distal at the mid common iliac artery.The balloon was inflated to 6 atm and deflated.Then the catheter was advanced to treat further up the lesion, but got stuck.The balloon was attempted to be inflated, but the pressure would not increase, thus it was assumed that the balloon had ruptured.In order to remove from the patient, the hub was cut off to advance a long 8f sheath over it, but would not pass beyond the mid-balloon.The physician decided to access the right groin to snare the wire from below.The guide wire and the distal portion of the device was removed through the femoral sheath and the proximal shaft was removed from the arm access.Upon removal, the balloon was observed to be damaged.The patient was fine.The physician stated this is not due to a failure with the device, but likely due to the severely calcified lesion.The procedure was completed with a balloon-expandable stent.This adverse event and product problem is being submitted due to a balloon rupture and the catheter getting stuck requiring additional intervention to complete the procedure.
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 or medical history are unknown.This information was not available from the facility.The angiosculpt device was returned for evaluation; however, the device evaluation has not yet begun, thus a supplemental report will be filed upon completion.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.
Additional Manufacturer Narrative
Block h3: the angiosculpt device was returned in 4 pieces.The proximal balloon separated radially with the scoring element intact to the distal portion of the balloon, but separated from the intermediate bond.The proximal balloon all the way to the proximal shaft was cut from the strain relief/hub portion.The inner member that belongs inside the shaft was removed and separated from the device.No functional testing was performed due to the nature of the returned device.Block h6: based on the information that was submitted in the initial mdr, the physician stated that the failure is not due to the device, but likely due to the severely calcified lesion.Per the ifu, retained device components is listed as a possible adverse effects of the procedure.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 OTW PTA
• Common Device Name: CATHETER, PTA, 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: 15272061
• Report Number: 3005462046-2022-00046
• Device Sequence Number: 6475772
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 11/16/2022
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G20110058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown