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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was performed to remove a coil.A 6mmx20cm.035 interlock 2d embolic coil was selected for use.The target location was located in an ovarian vein.After deployment, the physician noticed a wire hanging loose from the coil.The deployment was noted to be less smooth than normal.The coil was stretched from the ovarian vein into the iliac vein and vena cava.The physician decided to remove the coil via a snare.Another.035 interlock device was used and the procedure was completed successfully.There were no patient complications.
Event or Problem Description
It was reported that additional intervention was performed to remove a coil.A 6mmx20cm.035 interlock 2d embolic coil was selected for use.The target location was located in an ovarian vein.After deployment, the physician noticed a wire hanging loose from the coil.The deployment was noted to be less smooth than normal.The coil was stretched from the ovarian vein into the iliac vein and vena cava.The physician decided to remove the coil via a snare.Another.035 interlock device was used and the procedure was completed successfully.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this.035 interlock 2d embolic coil was analyzed.There were no identified failures or evidence that could be lost due to decontamination process.Media inspection of photos found that the coil was inside a recipient, the coil seemed to be stretched and kinked.Visual inspection showed that only a main coil was returned.The coil was found kinked and stretched.Microscopic inspection showed that the zap tip has a smooth surface and the interlocking arm was detached and not returned.Dimensional inspection found that there was distal fiber loss, due to the coil condition.

• 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: 11992605
• Report Number: 2134265-2021-07483
• Device Sequence Number: 922286
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026481627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention