MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.5mm x 150mm x 90cm sterling sl balloon catheter was selected for use.During unpacking, it was noticed that the balloon was damaged and a small hole of the balloon was noted.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks to the guidewire lumen 14.2cm, 14.3cm, and 14.8cm from the tip.Microscopic examination revealed a hole in the guidewire lumen 14.2cm from the tip.There is blood present in the guidewire lumen.The balloon is partially loosely folded.Media was provided by the customer in the form of 2 photos.The first photo is the label which contains information on the complaint device.The second photo is the device.The photo does appear to match the condition of the returned device.It shows an obvious kink to the guidewire lumen near the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.5mm x 150mm x 90cm sterling sl balloon catheter was selected to use.During unpacking, it was noticed that the balloon was damaged and a small hole of the balloon was noted.No patient complications were reported.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12238988
• Report Number: 2134265-2021-09539
• Device Sequence Number: 14390555
• Product Code: DQY
• UDI-Device Identifier: 08714729782452
• UDI-Public: 08714729782452
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 05/11/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0027288339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1