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

Model Number	2332-7040
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.Attempts to obtain this information has not been successful.The angiosculpt device was unable to deflate.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.During lab analysis, a shaft separation was observed.Patient information regarding relevant tests/ laboratory data or medical history are unknown.Attempts to obtain this information has not been successful.The angiosculpt device was returned in two pieces.Visual examination found a damaged distal bond with four leaflets lifted, but remained intact.The scoring element was misaligned with one bent strut.The intermediate bond was damaged with one ring lifted.The shaft was kinked and the transition tubing was severely stretched, accordion-like, and separated in two pieces.Due to the shaft separation, the balloon deflation issue could not be replicated.Based on the lab analysis, excessive exertion of force applied by the user was likely necessary in order to remove from the patient, resulting in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The balloon did not deflate completely.The customer was able to deflate enough to remove the balloon using a snare.A new device was used to complete the procedure.No patient injury occurred.
Event or Problem Description
The angiosculpt balloon was inflated three times under rbp (10-13 atm) with no issues.Per the physician, this may have been user error since the balloon may not have been entirely deflated when he attempted to withdraw from the patient, under the belief that it was fully deflated.Some contrast may have been left in the balloon, which possibly resulted in contrast to get trapped, then accumulate in the bulb of the balloon during retraction.The physician then attempted several times to re-inflate the balloon, but unable to do so.During removal, the device broke apart within the vessel, resulting in the need to snare it in its entirety.
Additional Manufacturer Narrative
Block b5: added additional complaint details provided by the facility.Block d11: provided size of introducer sheath and guide catheter.Block h6: based on the additional complaint details provided by the facility, user error likely caused or contributed to the shaft separation.Update to fda code 22 from the initial report: the ifu instructs to apply negative pressure to the inflation device and confirm the balloon is fully deflated prior to removing the angiosculpt catheter.H3 other text : placeholder.

• 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: 9508618
• Report Number: 3005462046-2019-00018
• Device Sequence Number: 16677606
• Product Code: PNO
• UDI-Device Identifier: 00813132022198
• UDI-Public: 00813132022198
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2019
• 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: 01/30/2022
• Device Model Number: 2332-7040
• Device Catalogue Number: 2332-7040
• Device Lot Number: G19010040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/22/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG: 6F GUIDE CATHETER; UNK MFG: 7F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005