MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the main coil was broken.The severely tortuous target lesion was located in a shut aneurysm in the left upper arm.A 4mmx8cm idc embolic coil was selected for use in the vascular embolization procedure.A 4f sheath and a rubicon support catheter were placed in the target lesion.Resistance was met at the detachment arm during placement of the idc embolic coil.Angiography was performed and it was confirmed that the idc coil was placed within the lesion.During the removal of the sheath it was observed that a small diameter piece of the idc coil remained in the sheath.Outside patient's body, it was noted that the main coil was broken.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the main coil was broken.The stenosed target lesion was located in left upper arm.A 4mmx8cm idc was selected for use.During procedure, it was noted that there was resistance met which the arm seemed to be caught and like a coil with a small diameter remained in the sheath.Outside patient's body, it was noted that the main coil was broken.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that during removal of the sheath, it was noted that the tip section of the coil near the interlocking arm was broken and was under the gauze.The physician believed that the coil was implanted.
Additional Manufacturer Narrative
E1: initial reporter address 1; (b)(6) e1: initial reporter city; (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1; (b)(6).E1: initial reporter city; (b)(6).Device evaluated by mfr: the device was returned for analysis.Visual inspection showed a main coil and pusher wire were returned for this complaint.The main coil was stretched and kinked, the zap tip was detached.The pusher wire was inspected, and it was found kinked.No more damages were found.Microscopic inspection of the pusher wire showed the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.The main coil zap tip was detached, and it was not returned.The interlocking arm was inspected, and no anomalies was noted.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.Also, the distal and proximal fiber bundles were found to be within specification.
Event or Problem Description
It was reported that the main coil was broken.The stenosed target lesion was located in left upper arm.A 4mmx8cm idc was selected for use.During procedure, it was noted that there was resistance met which the arm seemed to be caught and like a coil with a small diameter remained in the sheath.Outside patient's body, it was noted that the main coil was broken.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that during removal of the sheath, it was noted that the tip section of the coil near the interlocking arm was broken and was under the gauze.The physician believed that the coil was implanted.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11485944
• Report Number: 2134265-2021-03341
• Device Sequence Number: 3412959
• Product Code: KRD
• UDI-Device Identifier: 08714729158745
• UDI-Public: 08714729158745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141378
• 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,Followup
• Report Date (Section B): 04/21/2021

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 Expiration Date: 07/12/2023
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0025844588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 04/07/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 03/31/2021; 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1