MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 83787

Device Problems Premature Activation (1484); Physical Resistance/Sticking (4012)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the main coil and delivery wire were returned for this complaint.The delivery wire was inspected, and no anomalies were noticed.The coil returned was found kinked and stretched.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached and not returned.Dimensional inspection of the delivery wire and main coil was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2021.It was reported that the coil could not be pushed from the angiography catheter and became detached inside the introducer sheath.A 15mmx40cm interlock-35 coil was selected for use on a splenic artery aneurysm.During the procedure, it was noted that that the coil could not be pushed from the angiography catheter and detached inside the introducer sheath.The physician withdrew it out of the patient and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed a detached interlocking arm on the main coil.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12409281
• MDR Text Key: 269804762
• Report Number: 2134265-2021-11037
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0025973249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2020
• 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
• Patient Age: 53 YR
• Patient Weight: 62