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	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for analysis.A photo was attached by the customer and media inspection was performed.The picture shows that the coil and pusher wire were interlocked.It is confirmed that the device returned interlocked inside of introducer sheath.No damages were noticed by the media analysis.A delivery wire, introducer sheath and coil were returned for this complaint.The coil and delivery wire arms were 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.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, due the stretched condition.It was pulled out backwards in order to release the main coil.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no damages were noticed.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection of the delivery wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles on the main coil due to coil stretching.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 04may2021.It was reported that the coil was stuck in introducer sheath.The target lesion was located in the pelvic vein.A 10mmx20cm 2d interlock-35 coil was selected for use.During the procedure, when the physician tried to advance the push cable, it did not move, observing failure in the anchoring of the coil.It was noted that the device never came out of the protective hypotube and was not placed inside the patient.The procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.However, device analysis revealed missing fiber bundles.

• 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: 11851733
• Report Number: 2134265-2021-06333
• Device Sequence Number: 3767327
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 11/13/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024767809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1