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	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with arterial occlusion of the lower knee vessels and underwent artery vascular opening.The target lesion was located in anterior tibial artery.A 2.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.Inflations were performed three times.However, during third inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).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 that the inflation lumen is stretched 17.2cm from the hub.Microscopic examination revealed no damages.The device was attempted to be functionally tested by inflating it, but the damaged inflation lumen prevented fluid from reaching the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with arterial occlusion of the lower knee vessels and underwent artery vascular opening.The target lesion was located in anterior tibial artery.A 2.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.Inflations were performed three times.However, during third inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16344096
• Report Number: 2124215-2023-05761
• Device Sequence Number: 6300248
• Product Code: DQY
• UDI-Device Identifier: 08714729782261
• UDI-Public: 08714729782261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 06/23/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0029648955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG