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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 16-oct-2024.It was reported that the coil failed to advance and got stretched.The patient underwent an embolization of a splenic aneurysm in the splenic artery.A 15mm x 40mm interlock.035 coil was selected for use.During the procedure, the guidewire was used to puncture from the right side, and a non-boston scientific (bsc) angiography catheter was used to reach the embolization site.However, the physician had a hard time pushing this coil after the first coil was successfully deployed.After pushing it back and forth several times and pulling it out, it was found that the coil was unloaded in the angiography catheter.Consequently, the coil was stretched.After the catheter was replaced and the microcatheter was re-selected, the procedure was completed with a 14 x 30 coil.No complications were reported, and the patient was stable post-procedure.However, device analysis revealed the arm coil was detached.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic inspections were performed, and it was observed that the main coil, the rhv (rotating hemostasis valve), the introducer sheath and the delivery wire were returned stuck inside in the non-boston scientific (bsc) catheter.The delivery sheath and main coil were removed from the catheter, and it was observed that the main coil was bent and stretched at the coil arm, zap tip and primary coil section, moreover the arm coil was detached.Dimensional inspection on the main coil revealed that the components were within specifications.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK-35
• Common Device Name: 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: 20613804
• Report Number: 2124215-2024-65645
• Device Sequence Number: 12600988
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 05/29/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0031716348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - CORDIS 5F.
• Patient Sex: Female