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

Model Number	24703
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.The returned product consisted of a sterling sl balloon catheter stuck on an unknown introducer sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated 149cm from the hub while the balloon is separated 150.5cm from the hub.There is multiple buckling to the inflation lumen.Microscopic examination revealed no damages.The tip, marker band, distal section of the balloon and distal section of the guidewire lumen are all missing.Product analysis confirmed that there is a separation and found damage that would have contributed to the failure to deflate and froze on wire.
Event or Problem Description
It was reported that the balloon failed to deflate.A sterling balloon catheter was selected for use to treat stenosis in the proximal popliteal artery and distal superficial femoral artery (sfa).The target lesion was 97% occluded and heavily calcified.The procedure started as an outpatient procedure in the cardiac catheterization lab (ccl).Initial angiography showed a two-vessel runoff.The target lesion was crossed in the subintimal plane.A non-bsc balloon was used to dilate the subintimal plane.A non-bsc re-entry device was used; however, it could not track down to the lesion.A 6x70cm sheath was selected in order to create some pushability for the non-bsc re-entry device, however, the re-entry device broke.A different non-bsc re-entry device was selected.However, it repeatedly became entrapped on the guidewire.Additional angiography at this point revealed no flow to the foot.At this point, the physician decided the patient needed to be moved to the operating room (or) to be placed under anesthesia.Once in the or, pedal access was obtained, and the lesion was crossed.The 70cm sheath was replaced with a new 6x45cm non-bsc sheath.A sterling balloon catheter was advanced to the lesion.It was inflated successfully twice, but during the second deflation the balloon was unable to deflate.The sterling balloon was pulled into the sheath partially inflated.While attempting to pull the sheath and sterling balloon out, the sterling balloon became entrapped on the guidewire.Once some of the balloon was exposed, a pair of scissors was used to pop it.While pulling on the balloon, it ripped in half.The balloon tip was removed, and wire cutters were used to cut the wire though still maintaining up-and-over access.Another angiogram was performed and a perforation in the left iliac near the bifurcation was observed.The physician thought this occurred while exchanging the non-bsc 70cm sheath for the non-bsc 45cm sheath.The physician noted some resistance while inserting the 45cm sheath, and thought it was possible that a chunk of calcium tore off, maybe tearing a hole.At this point, code was called, and an open case was performed.

• 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: 18848741
• Report Number: 2124215-2024-10317
• Device Sequence Number: 15257927
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 12/14/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0030716504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female