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

Model Number	2332-8040
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h3: the angiosculpt device was returned intact to non-philips 6f introducer sheath.Visual inspection found the balloon was partially inflated and inverted at the distal end.The distal bond was damaged with two leaflets lifted but remained intact to the device.During functional testing, negative pressure was applied but the balloon was unable to deflate; therefore, the device was submerged in a hot water bath to dissolve any contrast.Then, a 0.018" laboratory guidewire was inserted through the device but encountered resistance at the y-joint of the hub.Using an indeflator filled with water, the device was pressurized but the balloon was unable to inflate.A leak was detected at the guidewire port; thus, a stopcock was used to plug the guidewire port and was pressurized again, but this time a leak was noted at the distal tip.To determine the cause, the strain relief was removed and found a separated inner member within the hub, resulting in the leaks identified at the guidewire port and distal tip.Block h6: based on the lab analysis, the balloon deflation issue was likely due to the separated inner member; however, the cause of the separation could not be established.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.Additionally, the angiosculpt device was inflated 4 atm above the rated burst pressure (rbp).The ifu warns that the balloon pressure should not exceed the rbp (12 atm) as indicated on the product label.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 catheter was used to treat a severely calcified lesion.The catheter was loaded over an 0.018" guidewire and advanced through the introducer sheath with no resistance noted.The balloon was inflated above the rated burst pressure (rbp) to 16 atm (rbp 12 atm) with no issues.However, during deflation, the balloon was unable to deflate.A cutdown approach was performed to retrieve the catheter.The procedure was completed with a new angiosculpt catheter.There was no patient injury reported.This product problem and adverse event is being submitted due to the balloon unable to deflate, requiring additional intervention.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-4541
• MDR Report Key: 18989655
• Report Number: 3005462046-2024-00008
• Device Sequence Number: 19550164
• Product Code: PNO
• UDI-Device Identifier: 00813132022204
• UDI-Public: (01)00813132022204(17)240519(10)G21050027
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 05/19/2024
• Device Model Number: 2332-8040
• Device Catalogue Number: 2332-8040
• Device Lot Number: G21050027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: ABBOTT: 0.018" STEEL CORE GUIDEWIRE; TERUMO: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown