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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint product was received for device analysis.Media inspection of the device was performed and it can be observed that the pusher wire was kinked.The pusher wire and the introducer sheath were returned for this complaint.Visual inspection was performed and revealed that the main coil and the pusher wire were not interlocked.The introducer sheath was inspected, and no damages were found.It is important to know that it was necessary to cut the introducer sheath due the main coil was inside the introducer sheath.The main coil was stretched, kinked and the interlocking arm was detached.Microscopic inspection of the device was performed and revealed that the interlocking arm of the main coil was detached and the pusher wire was detached at mid solder joint section.Dimensional inspection of the pusher wire was performed and revealed that the distal solder joint o.D and the mid solder joint o.D could not be measured due this part was detached from the main coil and it was not returned.The remaining measured dimensions were within specification.Dimensional inspection of the main coil was performed and revealed that the number of the fiber bundles do not meet the specification.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 (b)(6) 2022.It was reported that the coil could not be advanced from the catheter.A 22mm x 60cm interlock coil was selected for use in the abdominal aortic aneurysm.During the procedure, it was noted that the coil could not be advanced from the catheter.The coil was simply pulled out from the patient's body 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 and missing coil fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 12aug2022.It was reported that the coil could not be advanced from the catheter.A 22mm x 60cm interlock coil was selected for use in the abdominal aortic aneurysm.During the procedure, it was noted that the coil could not be advanced from the catheter.The coil was simply pulled out from the patient's body 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 and missing coil fiber bundles.
Additional Manufacturer Narrative
Correction to field e1: initial reporter first and last name from zhihong zhang to xue guanhua.Device evaluated by mfr: the complaint product was received for device analysis.Media inspection of the device was performed and it can be observed that the pusher wire was kinked.The pusher wire and the introducer sheath were returned for this complaint.Visual inspection was performed and revealed that the main coil and the pusher wire were not interlocked.The introducer sheath was inspected, and no damages were found.It is important to know that it was necessary to cut the introducer sheath due the main coil was inside the introducer sheath.The main coil was stretched, kinked and the interlocking arm was detached.Microscopic inspection of the device was performed and revealed that the interlocking arm of the main coil was detached and the pusher wire was detached at mid solder joint section.Dimensional inspection of the pusher wire was performed and revealed that the distal solder joint o.D and the mid solder joint o.D could not be measured due this part was detached from the main coil and it was not returned.The remaining measured dimensions were within specification.Dimensional inspection of the main coil was performed and revealed that the number of the fiber bundles do not meet the specification.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK
• Common Device Name: 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: 15375356
• Report Number: 2124215-2022-33206
• Device Sequence Number: 5797289
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 02/21/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027017455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 62 KG