MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number 10291

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that device damage occurred.A 32 x 2.50 rebel bms stent was selected for used.However, the hospital informed that the device is defective.There were no patient complications reported.However, returned device analysis revealed shaft detached.

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.Returned product consisted of the rebel bms stent delivery system with stent.The shafts, tip, stent, and balloon were microscopically and visually examined.There was contract in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded with the stent attached and secure between the markerbands.Inspection of the device revealed that there were numerous kinks throughout the hypotube and the hypotube was separated 32cm distal of the strain relief.The ends of the separation were ovaled, indicating that the hypotube was kinked prior to separation.

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15513757
• MDR Text Key: 306427083
• Report Number: 2134265-2022-08798
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 10291
• Device Catalogue Number: 10291
• Device Lot Number: 0021517743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1