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

Model Number	10273
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered and the shaft broke.The 80% in-stent restenosed lesion was in the calcified distal right coronary artery.Pre-dilation was performed with multiple compliant and non-compliant balloon catheters.After a 3.0mm stent was placed in the mid rca and additional 20 x 2.50 rebel bms stent was advanced and deployed in the distal rca.However, the delivery system was unable to be retracted or pulled out.The delivery system was inflated multiple times trying to dislodge it.The physician continued to pull on the delivery system during removal attempts but ended up losing guide placement.The guide wire and the delivery system came out but the balloon tip was left in the distal rca.No patient complications were reported.Further information has been requested but has not been provided at this time.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 04:18 pm ct.The report number is being corrected from: 2134265-2018-64435 to: 2134265-2018-62894.
Event or Problem Description
It was reported that removal difficulty was encountered and the shaft broke.The 80% in-stent restenosed lesion was in the calcified distal right coronary artery.Pre-dilation was performed with multiple compliant and non-compliant balloon catheters.After a 3.0mm stent was placed in the mid rca and additional 20 x 2.50 rebel bms stent was advanced and deployed in the distal rca.However, the delivery system was unable to be retracted or pulled out.The delivery system was inflated multiple times trying to dislodge it.The physician continued to pull on the delivery system during removal attempts but ended up losing guide placement.The guide wire and the delivery system came out but the balloon tip was left in the distal rca.No patient complications were reported.Further information has been requested but has not been provided at this time.Returned product consisted of a rebel bms balloon catheter.The remainder of the device that returned were visually and microscopically examined.Visual examination revealed that the distal section of the catheter is missing.The exit notch, distal shaft, entire guidewire lumen, balloon, marker bands, tip, and stent are all missing.From the hub to the separation is approximately 139.2cm.The separation appears to be rough on half of it and smooth on the other which is consistent with it possibly snagging on something prior to separation.There are multiple kinks along the whole device.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8071876
• Report Number: 2134265-2018-62894
• Device Sequence Number: 13867551
• Product Code: MAF
• UDI-Device Identifier: 08714729843832
• UDI-Public: 08714729843832
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: 10/22/2020
• Device Model Number: 10273
• Device Catalogue Number: 10273
• Device Lot Number: 0021291336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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
• Patient Age: 73 YR