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

Model Number 83787

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that coil protruded from catheter tip upon removal.The target lesion was located in a non-calcified abdominal aorta/ internal iliac artery.A 15mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil stopped moving back and forth from about 10cm beyond the contrast catheter and got stuck in the distal part of the catheter.While pushing and pulling, only the push wire was pulled out and the coil was removed from the body together with the contrast catheter.However, it was noted that the coil protruded from the catheter tip upon removal.Per physician's comment, thrombosis has probably developed inside the contrast catheter.The procedure was completed with another of the same device.No complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Unit returned with its original pouch.The unit returned has main coil stretched, as part of overall visual revision.Visual inspection revealed that the main coil was returned inside a cordis catheter.The main coil was stretched, kinked and the interlocking arm was detached.No more damages were found.Microscope inspection revealed that the interlocking arm of the main coil was detached.

Event Description

It was reported that coil protruded from catheter tip upon removal.The target lesion was located in a non-calcified abdominal aorta/ internal iliac artery.A 15mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil stopped moving back and forth from about 10cm beyond the contrast catheter and got stuck in the distal part of the catheter.While pushing and pulling, only the push wire was pulled out and the coil was removed from the body together with the contrast catheter.However, it was noted that the coil protruded from the catheter tip upon removal.Per physician's comment, thrombosis has probably developed inside the contrast catheter.The procedure was completed with another of the same device.No complications reported.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15204223
• MDR Text Key: 298603826
• Report Number: 2124215-2022-28674
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0028451737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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