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

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed: a delivery wire coil and introducer sheath were returned for this complaint.All parts were returned separated.The coil and delivery wire arms were not interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.The delivery wire was inspected, and no anomalies were noted.The main coil was kinked and stretched.No more damages were found in the returned device.Microscopic inspection on delivery wire: the proximal end has a smooth surface.The interlocking arm was inspected, and no damages were noticed.Microscopic inspection on main coil: the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached (part not returned).Dimensional inspection of the delivery wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that device could not be pushed further.The target lesion was located in the internal iliac artery.A 10mm x 20cm interlock-35 was selected for use.During the procedure, it was noted that the coil could not be pushed nor withdraw from the catheter after advancing for a half.Both coil and catheter were removed.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11957279
• Report Number: 2134265-2021-07297
• Device Sequence Number: 3542968
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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: 06/19/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023983184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 66