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

Model Number 83786

Device Problem Difficult to Insert (1316)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 18dec2023.It was reported that the coil could not be inserted into the catheter.A 10mm x 40cm interlock-35 was selected for use for embolization of an ovarian vein.Intermittent flushing of the interlock-35 coil was performed.While inserting the interlock-35 coil into a non-bsc catheter, resistance was noted at the proximal end of the catheter.The interlock-35 coil was withdrawn and removed from the catheter.The procedure was completed with a new device, same model.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil was returned with a non-boston scientific (bsc) catheter.The main coil was bent and stretched at the primary coil and the coil arm section was detached.A portion of the original pouch was returned, and it was observed that the pouch information matches with the complaint information.No further damages were observed.Functional testing could not be performed due to the main coil and the pusher wire were not interlocking.Dimensional inspection of the main coil revealed the components which could be measured were within specifications.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18376949
• MDR Text Key: 331379325
• Report Number: 2124215-2023-72299
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0031235866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• 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