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); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil fractured internally.An embold fibered 6x10 was selected for use.The physician was attempting to embolize a collateral vessel that originated off the brachial and was shunting flow to the cephalic vein in a dialysis shunt in the upper right arm.A 4f 0.038 non-boston scientific catheter and a renegade hi-flo- microcatheter were in place in the collateral vessel.While attempting to place an embold fibered 6x10 and reposition it, a portion of the coil appeared to not pull back into the microcatheter.It was presumed that the coil had fractured, and although a majority of the coil stayed in position in the vessel, what did remain was stretched.The microcatheter and coil pusher wire were removed as one unit to flush the microcatheter and ensure that no remnants of the coil remained in the catheter.The microcatheter was reinserted and the physician attempted to place an additional embold fibered 6x10 next to the remainder of the first embold fibered 6x10.Before the proximal release perforation was broken, the physician attempted to reposition the second coil, at which point both coils became entangled and were unintentionally pulled back into the microcatheter.It was presumed that the fractured portion of the first embold device had remained in the catheter, and the two coils had become caught on the fractured portion.The microcatheter and both coils were removed in their entirety.No portion of the fractured coil remained within the patient.The embolization procedure was completed using an alternate device.There were no reported patient complications.
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered coil 6x10.A 4fr angiographic non-boston scientific catheter and a renegade device were also returned.The introducer sheath and delivery wire were returned.The perforations on the delivery wire were not broken.Both couplers were still connected to the delivery wire via the pull wire.The coil was detached from the distal coil.Visual, microscopic and x-ray analysis was completed on the 4fr angiographic catheter.There were multiple bends on the angiographic catheter.It was observed that the coil was sticking out of the hub end of the angiographic catheter.It could not be removed.X-ray analysis showed that the first coil that was inserted and the second coil that was inserted were tangled together at the hub of the angiographic catheter.The returned renegade service showed multiple bends and kinks along the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for coil damage and withdrawing issues.
Additional Manufacturer Narrative
Correction in device analysis: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered coil 6x10.A 4fr angiographic non-boston scientific catheter and a renegade device were also returned.The introducer sheath and delivery wire were returned.The perforations on the delivery wire were not broken.Both couplers were still connected to the delivery wire via the pull wire.The coil was detached from the distal coupler.Visual, microscopic and x-ray analysis was completed on the 4fr angiographic catheter.There were multiple bends on the angiographic catheter.It was observed that the coils were sticking out of the hub end of the angiographic catheter.Both coils were removed from the hub.X-ray analysis showed that the first coil that was inserted and the second coil that was inserted were tangled together at the hub of the angiographic catheter.The returned renegade service showed multiple bends and kinks along the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for coil damage and withdrawing issues.
Event or Problem Description
It was reported that the coil fractured internally.An embold fibered 6x10 was selected for use.The physician was attempting to embolize a collateral vessel that originated off the brachial and was shunting flow to the cephalic vein in a dialysis shunt in the upper right arm.A 4f 0.038 non-boston scientific catheter and a renegade hi-flo- microcatheter were in place in the collateral vessel.While attempting to place an embold fibered 6x10 and reposition it, a portion of the coil appeared to not pull back into the microcatheter.It was presumed that the coil had fractured, and although a majority of the coil stayed in position in the vessel, what did remain was stretched.The microcatheter and coil pusher wire were removed as one unit to flush the microcatheter and ensure that no remnants of the coil remained in the catheter.The microcatheter was reinserted and the physician attempted to place an additional embold fibered 6x10 next to the remainder of the first embold fibered 6x10.Before the proximal release perforation was broken, the physician attempted to reposition the second coil, at which point both coils became entangled and were unintentionally pulled back into the microcatheter.It was presumed that the fractured portion of the first embold device had remained in the catheter, and the two coils had become caught on the fractured portion.The microcatheter and both coils were removed in their entirety.No portion of the fractured coil remained within the patient.The embolization procedure was completed using an alternate device.There were no reported patient complications.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• 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 CORPORATION; 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: 17616889
• Report Number: 2124215-2023-45584
• Device Sequence Number: 2599361
• Product Code: KRD
• UDI-Device Identifier: 08714729983606
• UDI-Public: 08714729983606
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/14/2023

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: 07/17/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029781053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOLD FIBERED 6X10; EMBOLD FIBERED 6X10; RENEGADE HI-FLO- MICROCATHETER; RENEGADE HI-FLO- MICROCATHETER
• Patient Sex: Unknown