MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83910
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil detached.The target lesion was located in the 1mm extremely tortuous prostate artery.A 2x4 embold fibered detachable coil system was selected for use in a complex embolization procedure.A 130 truselect microcatheter was advance to the vessel.The coil was pushed out of the microcatheter; however, the physician did not like the position so the coil was pulled back in to reposition.During repositioning, the coil was unable to be moved forward within the microcatheter.Resistance occurred through out the delivery.The coil wire was pulled out and it was noted that the coil was detached.The coil was unable to be removed from the microcatheter so the catheter was pulled out as well.Liquid embolic was given prior to the coil attempt.The physician noted that there could have been spasming in the vessel causing the coil detachment.There were no patient complications.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered 2x4 coil.A trueselect microcatheter was returned.The delivery wire and the nitinol shaft were returned in the polymer sheath.The returned delivery wire showed that it was not broken at the serration.The coupler was detached and separated from the delivery and the runner wire.The returned trueselect microcatheter showed no damage.The catheter was x-rayed and the embold coil was stuck inside the microcatheter.Inspection of the remainder of the device apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that the coil detached.The target lesion was located in the 1mm extremely tortuous prostate artery.A 2x4 embold fibered detachable coil system was selected for use in a complex embolization procedure.A 130 truselect microcatheter was advance to the vessel.The coil was pushed out of the microcatheter; however, the physician did not like the position so the coil was pulled back in to reposition.During repositioning, the coil was unable to be moved forward within the microcatheter.Resistance occurred through out the delivery.The coil wire was pulled out and it was noted that the coil was detached.The coil was unable to be removed from the microcatheter so the catheter was pulled out as well.Liquid embolic was given prior to the coil attempt.The physician noted that there could have been spasming in the vessel causing the coil detachment.There were no patient complications.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15461548
• Report Number: 2134265-2022-08713
• Device Sequence Number: 4273722
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 05/04/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029344168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown