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

Model Number	83787
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was stuck to the catheter tip during withdrawal.A 15mm x 25cm interlock-35 was selected for use in embolization of submaxillary arteriovenous malformations.During the procedure, after delivery of a small part, it was noted that the coil started to be stretched.The coil was attempted to be withdrawn but it failed.The device was removed along with the catheter.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the main coil, the introducer, and the pusher wire were returned for analysis.Blood was observed inside the introducer.It was visually and microscopically observed that the main coil was stretched, detached, and bent at the coil arm section.No other damages were observed on the device.Functional testing could not be performed since the main coil and the pusher wire were not interlocking.No other issues were identified during product analysis.
Event or Problem Description
It was reported that the coil was stuck to the catheter tip during withdrawal.A 15mm x 25cm interlock-35 was selected for use in embolization of submaxillary arteriovenous malformations.During the procedure, after delivery of a small part, it was noted that the coil started to be stretched.The coil was attempted to be withdrawn but it failed.The device was removed along with the catheter.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.

• 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 CORK LIMITED; 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: 17459329
• Report Number: 2124215-2023-39776
• Device Sequence Number: 11409105
• Product Code: KRD
• UDI-Device Identifier: 08714729793113
• UDI-Public: 08714729793113
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 08/24/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030021269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG