MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the moderately tortuous and non-calcified internal carotid to common carotid artery.After a filterwire ez guidewire crossed the lesion, a 4-30 sterlng balloon catheter was used for pre-dilatation, followed by placement of a 10-31 carotid wallstent.A 5.5mmx20mmx135cm sterling balloon catheter was then advanced for post-dilatation.However, during inflation, leakage of contrast agent and pinhole leak was observed.The procedure was completed as the required expansion was obtained.Post-procedure, visual dilatation with saline solution was performed but no major leak or image was observed in the balloon material.No known patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 32.3cm distal from the strain relief.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.No issues were detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the moderately tortuous and non-calcified internal carotid to common carotid artery.After a filterwire ez guidewire crossed the lesion, a 4-30 sterlng balloon catheter was used for pre-dilatation, followed by placement of a 10-31 carotid wallstent.A 5.5mmx20mmx135cm sterling balloon catheter was then advanced for post-dilatation.However, during inflation, leakage of contrast agent and pinhole leak was observed.The procedure was completed as the required expansion was obtained.Post-procedure, visual dilatation with saline solution was performed but no major leak or image was observed in the balloon material.No known patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10340868
• Report Number: 2134265-2020-10099
• Device Sequence Number: 14317344
• Product Code: DQY
• UDI-Device Identifier: 08714729755579
• UDI-Public: 08714729755579
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0023077502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: GUIDE CATHETER: LAUNCHER 8F 90CM STR; GUIDE CATHETER: LAUNCHER 8F 90CM STR; INTRODUCER SHEATH: TERUMO 8FR 40CM; INTRODUCER SHEATH: TERUMO 8FR 40CM; STENT: CAROTID WALLSTENT 10-31; STENT: CAROTID WALLSTENT 10-31