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

Model Number	83786
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.Device evaluated by mfr.: the device was returned for evaluation.Visual inspection observed only the main coil being returned.The main coil was also observed to be stretched and the interlocking arm was detached.Microscopic analysis of the device noted that the delivery wire was not returned and the main coil was stretched near the interlocking arm and the interlocking arm was detached.The number of proximal fiber bundles were below specification observed upon dimensional inspection.The number of distal fiber bundles as well as the outer diameter of the zap tip and primary coil were noted to be within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that the main coil was stretched.The target area was located in a moderately tortuous internal iliac artery.During procedure, after an imager bern catheter was inserted via cross over approach, a 6mm x 20cm and a 4mm x 6cm interlock coil were deployed.A 3mm x 4cm.035 interlock coil was used for embolization.Subsequently, the 3mm x 4cm.035 interlock was inserted; however, the coil became unraveled/stretched.The device was removed from the patient's body and imaging was performed.The blood flow was blocked, thus, the procedure was ended.There were no patient complications reported.However, device analysis revealed a detached interlocking arm.

• 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: 9119134
• Report Number: 2134265-2019-11614
• Device Sequence Number: 1848675
• Product Code: KRD
• UDI-Device Identifier: 08714729793151
• UDI-Public: 08714729793151
• 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
• Report Date (Section B): 09/25/2019

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: 11/30/2019
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0019914807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1