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 Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.The target lesion was located in the severely tortuous and severely calcified aneurysm.Four interlock-35 coils of different sizes, namely, 12mmx20cm, 12mmx40cm, 10mmx40cm, and 15mmx40cm, were selected for use.During the procedure, it was noted that the coils became stuck in the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address: (b)(6).
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.The target lesion was located in the severely tortuous and severely calcified aneurysm.Four interlock-35 coils of different sizes, namely, 12mmx20cm, 12mmx40cm, 10mmx40cm, and 15mmx40cm, were selected for use.During the procedure, it was noted that the coils became stuck in the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with a different device.No patient complications were reported.It was further reported that the coils became stuck in the middle part of the catheter.Upon removal together with the catheter, the coils did not protrude from the tip of the catheter.

• 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: 10115128
• Report Number: 2134265-2020-07383
• Device Sequence Number: 1762836
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 09/04/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024380025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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 - COOK; INTRODUCER SHEATH - 6F TERUMO; INTRODUCER SHEATH - 6F TERUMO; MICRO CATHETER - BREAKTHROUGH 2M; MICRO CATHETER - IMPRESS; INTRODUCER SHEATH - 6F TERUMO; MICRO CATHETER - BREAKTHROUGH 2M