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

Model Number	2332-8040
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, gender, weight, ethnicity and race are unknown.This information was not available from the facility.During the procedure, the angiosculpt device was unable to deflate.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.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, investigation is ongoing and results are not yet available.A supplemental mdr to follow upon completion of investigation.
Event or Problem Description
The device was used in a highly calcified iliac lesion, but a straight segment with no tortuosity.After inflation, the angiosculpt balloon would not deflate.The back end of a guidewire was used to deflate and pop the balloon.During withdrawal, the device was unable to be withdrawn through the sheath due to a tangled scoring element.The user decided to upsize to a 8 fr sheath, but it still would not encapsulate the entire balloon.The balloon and scoring element were hanging outside of the sheath.The sheath and exposed balloon were removed through anastomosis.No patient injury reported.
Additional Manufacturer Narrative
Block h3: the angiosculpt catheter was returned loaded onto a 7fr introducer sheath.The distal tip of the introducer sheath was found damaged.The proximal balloon leg appeared necked and a damaged distal tip was noted with 1 scoring element strut bent at the link.In addition, the transition tubing was wrinkled and 2 shaft kinks (possibly from handling during return) were observed.The introducer sheath was unable to be removed from the device due to the balloon profile.During functional testing, a laboratory 0.018" guide wire was inserted through the distal tip, but was unable to pass due to resistance at the proximal end of the transition tubing.With partial guide wire support, using an indeflator filled with 50/50 contrast/saline solution, the balloon was pressurized to nominal and took approximately 1 min to fully inflate.No leaks were observed.Then, the balloon was deflated and took approximately 3 min 40 sec to fully deflate.Per specification, inflation time is approximately 20 seconds and deflation is approximately 35 seconds.Block h6: based on the lab analysis, the necked proximal balloon leg may have caused or contributed to the balloon deflation problem.A review of the device history record and manufacturing process could not confirm a cause related to design and/or process failure.
Event or Problem Description
The device was used in a highly calcified iliac lesion, but a straight segment with no tortuosity.After inflation, the angiosculpt balloon would not deflate so they pulled it back to the distal iliac to try to get it to deflate.Then, an attempt to pop the balloon with the back end of a 0.014" guidewire was performed; however the balloon did not pop.The 7f introducer sheath would not encapsulate the entire balloon (the balloon material and the wires were hanging outside the sheath), thus it was decided to remove as a unit.The physician proceeded to move the sheath and exposed balloon out through anastomosis.After the device was removed as a unit, they upsized to a 8fr sheath to complete stenting.The angiogram was received on (b)(6) 2021.Review of the angiogram revealed the case started with an omniflush or universal flush catheter in the aorta from the right common femoral access- digital subtraction angiography revealed a calcified distal aorta and a calcified and severely narrowed lesion in the left common iliac ostium with post stenotic dilatation of the distal common iliac artery.After access was obtained from the left femoral, the lesion was treated with a csi diamondback catheter (presumably a 2.0mm or 2.25mm burr) to modify the lesion.Then, the angiosculpt balloon was centered in the lesion and fully inflated (the distal end of the balloon was in the distal aorta).The next image shows the inflated balloon to be pulled back into the left common and external iliac arteries.The ostium of the common iliac seems to be much better expanded, but still appeared to be smaller in diameter than the balloon.It was reported that the physician attempted to deflate the balloon by puncturing it with the back end of a wire, however that was not shown on the shared angios.Additionally, the report said that the sheath was changed to an 8fr, however that is impossible to do without removing the balloon first (or cutting off the proximal shaft of the balloon which was not done).It is suspected that the reported ¿unraveled wires¿ (scoring nitinol elements) occurred when the inflated balloon was pulled back from the lesion into the distal common iliac (presumably in an attempt to perfuse the left leg).The last angio showed a well deployed stent in the proximal left common iliac artery with excellent flow down the left leg.It is believed that stenting of this lesion was a preplanned event, as this is a common interventional practice for the treatment of severe and calcified iliac lesions (especially ostial lesions).
Additional Manufacturer Narrative
Block b5: complaint details updated and provided angiogram assessment.Block d11: guidewire size was corrected from 0.014" to 0.018".Introducer sheath manufacturer name obtained and size was corrected from 6f to 7f.Block h3/h6: complaint investigation is ongoing and not yet complete.A supplemental mdr to follow upon completion.

• 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: 11172689
• Report Number: 3005462046-2021-00001
• Device Sequence Number: 14263269
• Product Code: PNO
• UDI-Device Identifier: 00813132022204
• UDI-Public: 00813132022204
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150634
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2020

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: 08/02/2022
• Device Model Number: 2332-8040
• Device Catalogue Number: 2332-8040
• Device Lot Number: G19070040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 02/12/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/12/2021; 03/12/2021
• 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: TERUMO: 0.014" ADVANTAGE GUIDE WIRE; TERUMO: 0.018" GLIDEWIRE ADVANTAGE GUIDE WIRE; TERUMO: 7F INTRODUCER SHEATH; UNK MFG: 6F INTRODUCER SHEATH; TERUMO: 0.014" ADVANTAGE GUIDE WIRE; UNK MFG: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention