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

Model Number	M001394240220600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil became stuck and had to be snared.A 22mm x 60cm embold fibered coil was selected for use in the embolization of an aneurysm directly off of the aorta.It had previously been embolized with a number of coils approximately a month prior, but it was continuing to grow.A 5f non-boston scientific (bsc) angiographic catheter and a 2.3f non-bsc microcatheter were used for access.Intermittent flush was performed.Four 32mm x 60cm embold fibered coils were deployed successfully.Next, an attempt was made to deploy this 22mm x 60cm embold fibered coil.Part of the coil began to coil in the pack as expected, but resistance was met when there was about 10cm of the coil left inside the microcatheter.The coil could no longer be advanced or retracted.It was unknown if the coil was stuck in the coil pack or in the catheter.An attempt was made to take out the microcatheter system, but the distal portion of the coil remained in the coil pack while the rest of the coil continued to unravel all the way out of the 5f catheter.The physician successfully flushed the intact coil into the pack, but the unraveled portion remained in the 5f catheter.The physician tried pushing with multiple different wires and flushing with small syringes, but nothing worked.Microsnares were used to slowly remove the unraveled coil piece by piece, but the entire unraveled coil could not be removed.The patient was due to get an aortic stent graft the following day, so the physician consulted vascular surgery.They recommended removing the 5f catheter and attempting to use a bigger snare to remove as much of the remaining coil as possible.A non-bsc snare catheter was able to be used to remove more of the stretched coil.The unretrieved portion of the coil was partially in the coil pack and partially stretched into the aorta.It did not migrate.The plan from there was for the patient to go to the operating room that night to get the stent graft placed, with the hopes that the stent would push the remaining coil up against the wall of the aorta and prevent it from migrating.At this time, there were no patient complications as a result of this event, and the patient was doing well.Patient progress would be monitored.The patient was expected to fully recover.It was confirmed that the stent graft procedure successfully walled off the coil pack.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of an embold fibered system with perforations intact.The coil received was broken in three separate pieces.Microscopic examination revealed the coil broke from the coupler, but the coupler was still attached to the delivery wire.Additionally, media submitted from the customer was thoroughly examined and evaluated to reveal a coil pack with a stretched coil protruding from the target location with a section of the stretched coil in the catheter.The reported events were confirmed.
Event or Problem Description
It was reported that the coil became stuck and had to be snared.A 22mm x 60cm embold fibered coil was selected for use in the embolization of an aneurysm directly off of the aorta.It had previously been embolized with a number of coils approximately a month prior, but it was continuing to grow.A 5f non-boston scientific (bsc) angiographic catheter and a 2.3f non-bsc microcatheter were used for access.Intermittent flush was performed.Four 32mm x 60cm embold fibered coils were deployed successfully.Next, an attempt was made to deploy this 22mm x 60cm embold fibered coil.Part of the coil began to coil in the pack as expected, but resistance was met when there was about 10cm of the coil left inside the microcatheter.The coil could no longer be advanced or retracted.It was unknown if the coil was stuck in the coil pack or in the catheter.An attempt was made to take out the microcatheter system, but the distal portion of the coil remained in the coil pack while the rest of the coil continued to unravel all the way out of the 5f catheter.The physician successfully flushed the intact coil into the pack, but the unraveled portion remained in the 5f catheter.The physician tried pushing with multiple different wires and flushing with small syringes, but nothing worked.Microsnares were used to slowly remove the unraveled coil piece by piece, but the entire unraveled coil could not be removed.The patient was due to get an aortic stent graft the following day, so the physician consulted vascular surgery.They recommended removing the 5f catheter and attempting to use a bigger snare to remove as much of the remaining coil as possible.A non-bsc snare catheter was able to be used to remove more of the stretched coil.The unretrieved portion of the coil was partially in the coil pack and partially stretched into the aorta.It did not migrate.The plan from there was for the patient to go to the operating room that night to get the stent graft placed, with the hopes that the stent would push the remaining coil up against the wall of the aorta and prevent it from migrating.At this time, there were no patient complications as a result of this event, and the patient was doing well.Patient progress would be monitored.The patient was expected to fully recover.It was confirmed that the stent graft procedure successfully walled off the coil pack.
Event or Problem Description
It was reported that the coil became stuck and had to be snared.A 22mm x 60cm embold fibered coil was selected for use in the embolization of an aneurysm directly off of the aorta.It had previously been embolized with a number of coils approximately a month prior, but it was continuing to grow.A 5f non-boston scientific (bsc) angiographic catheter and a 2.3f non-bsc microcatheter were used for access.Intermittent flush was performed.Four 32mm x 60cm embold fibered coils were deployed successfully.Next, an attempt was made to deploy this 22mm x 60cm embold fibered coil.Part of the coil began to coil in the pack as expected, but resistance was met when there was about 10cm of the coil left inside the microcatheter.The coil could no longer be advanced or retracted.It was unknown if the coil was stuck in the coil pack or in the catheter.An attempt was made to take out the microcatheter system, but the distal portion of the coil remained in the coil pack while the rest of the coil continued to unravel all the way out of the 5f catheter.The physician successfully flushed the intact coil into the pack, but the unraveled portion remained in the 5f catheter.The physician tried pushing with multiple different wires and flushing with small syringes, but nothing worked.Microsnares were used to slowly remove the unraveled coil piece by piece, but the entire unraveled coil could not be removed.The patient was due to get an aortic stent graft the following day, so the physician consulted vascular surgery.They recommended removing the 5f catheter and attempting to use a bigger snare to remove as much of the remaining coil as possible.A non-bsc snare catheter was able to be used to remove more of the stretched coil.The unretrieved portion of the coil was partially in the coil pack and partially stretched into the aorta.It did not migrate.The plan from there was for the patient to go to the operating room that night to get the stent graft placed, with the hopes that the stent would push the remaining coil up against the wall of the aorta and prevent it from migrating.At this time, there were no patient complications as a result of this event, and the patient was doing well.Patient progress would be monitored.The patient was expected to fully recover.It was confirmed that the stent graft procedure successfully walled off the coil pack.
Additional Manufacturer Narrative
Updated: e1: initial reporter email.Device eval by manufacturer: the returned device consisted of an embold fibered system with perforations intact.The coil received was broken in three separate pieces.Microscopic examination revealed the coil broke from the coupler, but the coupler was still attached to the delivery wire.Additionally, media submitted from the customer was thoroughly examined and evaluated to reveal a coil pack with a stretched coil protruding from the target location with a section of the stretched coil in the catheter.The reported events were confirmed.

• Brand Name: EMBOLD? FIBERED
• 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: 22340536
• Report Number: 2124215-2025-42379
• Device Sequence Number: 21081151
• Product Code: KRD
• UDI-Device Identifier: 08714729983743
• UDI-Public: (01)08714729983743(17)280224(10)35923537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/10/2025

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 Model Number: M001394240220600
• Device Catalogue Number: M001394240220600
• Device Lot Number: 0035923537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 11/10/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/29/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK MEDICAL MICKELSON ANGIOGRAPHIC CATHETER.; COOK MEDICAL MICKELSON ANGIOGRAPHIC CATHETER.; COOK MEDICAL MICKELSON ANGIOGRAPHIC CATHETER.; MERIT ENSNARE SYSTEM.; MERIT ENSNARE SYSTEM.; MERIT ENSNARE SYSTEM.; PROWLER PLUS MICROCATHETER.; PROWLER PLUS MICROCATHETER.; PROWLER PLUS MICROCATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male