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

Model Number	20188
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified vertebral artery.A 5.0mm x 15mm x 150cm express sd renal/biliary stent was advanced to treat the lesion.However, during initial inflation at 6 atmospheres, the balloon ruptured.The device was removed with a snare and the procedure was completed with a different device.There were no patient complications reported and the patient status was normal.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified vertebral artery.A 5.0mm x 15mm x 150cm express sd renal/biliary stent was advanced to treat the lesion.However, during initial inflation at 6 atmospheres, the balloon ruptured.The device was removed with a snare and the procedure was completed with a different device.There were no patient complications reported and the patient status was normal.
Additional Manufacturer Narrative
Device evaluated by mfr.: the express sd was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The express sd had visible flattening and stretching of the entire length of the catheter.The most prominent stretching was found 23 cm to 32 cm from the tip and again 36.1 cm from the tip.A rupture of the shaft was confirmed 23cm from the tip.The stent was not returned.Device analysis determined the condition of the returned device was consistent with the reported information of a material rupture.Because there was no evidence of any product quality deficiencies, it was considered likely that the buckling and flattening were attributable to procedural issues.E1 - initial reporter facility name: (b)(6).

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14116204
• Report Number: 2134265-2022-03500
• Device Sequence Number: 14026205
• Product Code: NIN
• UDI-Device Identifier: 08714729390398
• UDI-Public: 08714729390398
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152607
• 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,Followup
• Report Date (Section B): 06/16/2022

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: 11/07/2024
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0028344625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown