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

Model Number	83095
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil fracture occurred.A 2mmx4mm vortx- 35 coil was selected for use localization with coil procedure prior to radiotherapy of a lung tumor.The target lesion was a mild to none tortuous.During the procedure, the coil was introduced into the non-bsc catheter, a guidewire was used to push the coil through the catheter.The coil was intermittent flushed out.When the distal part of the coil came out of the tip of the catheter it was noticed that the coil was very stretched and did not form the shape.The physician pulled out the guidewire and noticed that there was a very thin wire of the coil located at the hub.The coil was removed with the catheter from the patient by pulling out the catheter.The procedure was successfully completed with another of the coil and catheter devices and everything was fine.There were no patient complications reported and the patient was ok post procedure.
Event or Problem Description
It was reported that coil fracture occurred.A 2mmx4mm vortx- 35 coil was selected for use localization with coil procedure prior to radiotherapy of a lung tumor.The target lesion was a mild to none tortuous.During the procedure, the coil was introduced into the non-bsc catheter, a guidewire was used to push the coil through the catheter.The coil was intermittent flushed out.When the distal part of the coil came out of the tip of the catheter it was noticed that the coil was very stretched and did not form the shape.The physician pulled out the guidewire and noticed that there was a very thin wire of the coil located at the hub.The coil was removed with the catheter from the patient by pulling out the catheter.The procedure was successfully completed with another of the coil and catheter devices and everything was fine.There were no patient complications reported and the patient was ok post procedure.It was further reported that the coil was stretched from the hub until the tip of the catheter and there was nothing detached from the main coil.
Event or Problem Description
It was reported that coil fracture occurred.A 2mmx4mm vortx- 35 coil was selected for use localization with coil procedure prior to radiotherapy of a lung tumor.The target lesion was a mild to none tortuous.During the procedure, the coil was introduced into the non-bsc catheter, a guidewire was used to push the coil through the catheter.The coil was intermittent flushed out.When the distal part of the coil came out of the tip of the catheter it was noticed that the coil was very stretched and did not form the shape.The physician pulled out the guidewire and noticed that there was a very thin wire of the coil located at the hub.The coil was removed with the catheter from the patient by pulling out the catheter.The procedure was successfully completed with another of the coil and catheter devices and everything was fine.There were no patient complications reported and the patient was ok post procedure.It was further reported that the coil was stretched from the hub until the tip of the catheter and there was nothing detached from the main coil.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a vortx 35 coil.Only the main coil was returned for this complaint.Visual inspection of the analysis of the returned product revealed that the main coil was found kinked and stretched.Microscopic examination of the zap tip (apex and base) revealed no damages.Dimensional measurement found that the apex zap tip, base zap tip, and fiber bundles were within specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: VORTX - 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: 9842389
• Report Number: 2134265-2020-03381
• Device Sequence Number: 2856005
• Product Code: KRD
• UDI-Device Identifier: 08714729237273
• UDI-Public: 08714729237273
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2020

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: 10/09/2022
• Device Model Number: 83095
• Device Catalogue Number: 83095
• Device Lot Number: 0024575560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 05/21/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/07/2020; 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS - MPA 4FR 0.038 CATHETER; CORDIS - MPA 4FR 0.038 CATHETER; CORDIS - MPA 4FR 0.038 CATHETER