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

Model Number	24690
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling 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 in the balloon 33mm 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.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that shaft leak occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery.After a 6fr non-boston scientific (bsc) introducer sheath was introduced and a non-bsc guidewire crossed the lesion, the lesion was confirmed with intravascular ultrasound.Dilatation was attempted with a non-bsc balloon catheter but the balloon ruptured due to calcification.Subsequently, a 4.0mmx60mmx135cm sterling balloon catheter was advanced; however, during inflation, the pressure did not increase.The balloon catheter was removed from the sheath and upon closer inspection of the catheter, it was found that the contrast medium was leaking from the shaft of the balloon catheter so inflation could not be performed.The procedure was completed with a 4mm, 4cm non-bsc balloon catheter at 20 atmospheres.There were no patient complications reported.However, returned device analysis revealed balloon pinhole.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15321152
• Report Number: 2124215-2022-30471
• Device Sequence Number: 5124835
• Product Code: DQY
• UDI-Device Identifier: 08714729757016
• UDI-Public: 08714729757016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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
• Report Date (Section B): 08/30/2022

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: 02/05/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0026761836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: BALLOON CATHETER USED- SABERX3MM4CM; GUIDEWIRE USED- VASSALO FLOPPY; INFLATION DEVICE USED- EVEREST; INTRODUCER SHEATH USED - PARENT SHEATH 6F; MICRO CATHETER USED- CORSIR PV; STENT USED- SUPERA
• Patient Sex: Unknown