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

Model Number	24716
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0x220x150 sterling balloon catheter was advanced for dilatation using an encore 26 inflation device.However, during the procedure, it was noted that the balloon could not be deflated.The inflation device was swapped with a non-boston scientific product which did not work either.The balloon had to be extracted while still inflated.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0x220x150 sterling balloon catheter was advanced for dilatation using an encore 26 inflation device.However, during the procedure, it was noted that the balloon could not be deflated.The inflation device was swapped with a non-boston scientific product which did not work either.The balloon had to be extracted while still inflated.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported and the patient's status was stable.
Additional Manufacturer Narrative
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 and microscopic examination revealed no damages.The balloon is loosely folded and there is blood inside the guidewire lumen.The balloon was functionally tested by inflating it to rated burst pressure and it was able to hold pressure.The balloon was deflated and there were no issues deflating it.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported failure to deflate.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12368503
• Report Number: 2134265-2021-10321
• Device Sequence Number: 4333809
• Product Code: LIT
• UDI-Device Identifier: 08714729860310
• UDI-Public: 08714729860310
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0027302780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention