MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	20188
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removing the stent occurred.An existing stent was in place with high grade stenosis.The target lesion was located in the renal artery and was pre-dilated with a 6x20.018 non-bsc balloon for 1 minute.Following exchange of v-18 guidewire for an amplatz, a sheath was advanced through the existing stent.A 7.0mmx15mmx150cm express sd stent balloon was sent through the sheath and the balloon inflated to 14 atmospheres for 1 minute.However, after deflation, the balloon would not withdraw.There was no kink or twist in the sheath, and the wire had to be pulled to withdraw the balloon.Upon visual inspection, it appeared that the balloon did not rewrap.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that difficulty removing the stent occurred.An existing stent was in place with high grade stenosis.The target lesion was located in the renal artery and was pre-dilated with a 6x20.018 non-bsc balloon for 1 minute.Following exchange of v-18 guidewire for an amplatz, a sheath was advanced through the existing stent.A 7.0mmx15mmx150cm express sd stent balloon was sent through the sheath and the balloon inflated to 14 atmospheres for 1 minute.However, after deflation, the balloon would not withdraw.There was no kink or twist in the sheath, and the wire had to be pulled to withdraw the balloon.Upon visual inspection, it appeared that the balloon did not rewrap.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks and multiple stretching along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.Product analysis confirmed the device was stretched which confirms there was difficulty removing the device.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 20280731
• Report Number: 2124215-2024-58442
• Device Sequence Number: 7563936
• Product Code: NIN
• UDI-Device Identifier: 08714729390435
• UDI-Public: 08714729390435
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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 Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0033256341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Patient Sex: Unknown