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

Model Number	24715
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted.A 6.0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent.Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times.However, during removal, the balloon was stuck with the guide wire and it could not be removed.Subsequently, the device was removed as a set with the guidewire and the procedure was completed.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluation by mfr.: the returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The inner shaft was separated from the manifold.The outer shaft was buckled at 111.2cm for 13mm and at 115.4cm for 1mm.The outer shaft was stretched down starting at 120.8cm for approximately 10cm.The inner shaft was buckled 131.5cm from the strain relief for 10.6cm extending distally and 6mm proximal of the tip for 23mm extending proximally.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a guidewire in the device that could not be removed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted.A 6.0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent.Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times.However, during removal, the balloon was stuck with the guide wire and it could not be removed.Subsequently, the device was removed as a set with the guidewire and the procedure was completed.No patient complications nor injuries were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11362093
• Report Number: 2134265-2021-02151
• Device Sequence Number: 3383553
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: 08714729845447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132430
• 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): 05/06/2021

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: 10/26/2021
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0025479424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: THRUWAY 18; GUIDEWIRE: THRUWAY 18; INTRODUCER SHEATH: PARENT 6FR; INTRODUCER SHEATH: PARENT 6FR; STENT: ELUVIA 6X120 AND 7X120; STENT: ELUVIA 6X120 AND 7X120