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

Model Number	83786
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A delivery wire and main coil were returned for this complaint.The main coil was inspected and was found kinked and stretched.The delivery wire was inspected and no anomalies was noted.No more damages were found.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 anomalies was noted.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 was performed.The measured dimensions on the delivery wire were within specification.There were missing fiber bundles on the main coil due to coil condition.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 25nov2020.It was reported that the coil was unable to cross the catheter.A 10mmx40cm cube interlock-35 coil was selected for use.During the procedure, it was noted that the coil got stuck in the catheter distal part despite the other coils of similar being fine.Furthermore, it was noted that the coil completely unraveled and almost was unretrievable, and protruded in the catheter's tip during removal.This affected the base catheter and a 8mm x 20cm interlock-35 coil was unable to pass so they had to replace the base catheter.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a loss of fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that the coil was unable to cross the catheter.A 10mmx40cm cube interlock-35 coil was selected for use.During the procedure, it was noted that the coil got stuck in the catheter distal part despite the other coils of similar being fine.Furthermore, it was noted that the coil completely unraveled and almost was unretrievable, and protruded in the catheter's tip during removal.This affected the base catheter and a 8mm x 20cm interlock-35 coil was unable to pass so they had to replace the base catheter.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a loss of fiber bundles.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A delivery wire and main coil were returned for this complaint.The main coil was inspected and was found kinked and stretched.The delivery wire was inspected and no anomalies was noted.No more damages were found.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 anomalies was noted.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 was performed.The measured dimensions on the delivery wire were within specification.There were missing fiber bundles on the main coil due to coil condition.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.Correction to field h6: evaluation conclusion code from 'adverse event related to procedure - 4311' to 'failure to follow instructions - 18'.

• 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: 10971593
• Report Number: 2134265-2020-17204
• Device Sequence Number: 17217236
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 02/04/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025160151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - MERIT 5F C2; CATHETER - MERIT 5F C2; COIL - 10MMX40CM CUBE INTERLOCK-35; COIL - 10MMX40CM CUBE INTERLOCK-35; CATHETER - MERIT 5F C2; COIL - 10MMX40CM CUBE INTERLOCK-35