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

Model Number	24703
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name:(b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in the left subclavian artery to brachial artery.An 8f long non-boston scientific (bsc) introducer sheath punctured in supine position in the femoral artery.After a v-18 guidewire crossed the lesion, a 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during the pressurization, there was leakage at the tail end of the balloon.The device was removed, and it was noticed a spray at the tail end.Another of the same device was used and the procedure was completed.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the long subclavian artery.An 8f non-bsc introducer sheath was inserted.After a v-18 guidewire crossed the lesion, the balloon reached the lesion.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during the procedure, there was leakage at the tail end of the balloon.The device was removed and noticed that there was a spray at the tail end.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the 85% stenosed 2 shaped arch target lesion was located in the moderately tortuous and moderately calcified long subclavian artery.The balloon was inflated once at 5 atmospheres for 10 seconds before it was noticed a visible pinhole at the end of the balloon.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.E1: initial reporter facility name: (b)(6) university.E1: initial reporter phone: (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 no damages.Microscopic examination revealed a pinhole 15.6cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• 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: 17562872
• Report Number: 2124215-2023-43732
• Device Sequence Number: 6684461
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 12/18/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0030735242
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V-18 GUIDE WIRE; GUIDEWIRE: V-18 GUIDE WIRE; INTRODUCER SHEATH: COOK 8F LONG SHEATH; INTRODUCER SHEATH: COOK 8F LONG SHEATH
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG