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

Model Number	24703
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The more than 50% stenosed target lesion was located in the lower limb artery below the knee.After a 200cm, 8cm v-18 control wire was used to cross the lesion, a 3.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.Upon removal of the balloon, it was noted that the balloon not able to slide over the guidewire and the wire was stuck inside the balloon shaft.Both devices were pulled-out of the sheath as one unit.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that removal difficulties were encountered.The more than 50% stenosed target lesion was located in the lower limb artery below the knee.After a 200cm, 8cm v-18 control wire was used to cross the lesion, a 3.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.Upon removal of the balloon, it was noted that the balloon not able to slide over the guidewire and the wire was stuck inside the balloon shaft.Both devices were pulled-out of the sheath as one unit.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
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 buckling to the guidewire lumen 8cm and 80.5cm from the hub.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage on the device that would have contributed to the froze on wire.

• 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: 12218601
• Report Number: 2134265-2021-09247
• Device Sequence Number: 3621317
• Product Code: DQY
• UDI-Device Identifier: 08714729782490
• UDI-Public: 08714729782490
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 02/15/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0026807830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1