MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05661.It was reported that the burr became stuck in lesion and rotaburr and rotawire device separation occurred.It is possible that the separated pieces remained inside of the patient¿s body.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 2.00mm rotalink¿ plus and a 330cm rotawire¿ and wireclip¿ torquer were selected for use for the percutaneous coronary intervention (pci).An unspecified 8fr sheath and an 8fr mach1 guiding catheter were used during the procedure.After pre-dilatation was done using an unspecified balloon on the lesion area, ablation was performed using the 2.00mm rotalink plus.After several ablations were performed, the burr was passed through the lesion.However, when ablation was performed again, it was noted that the burr became stuck in the lesion area.The burr was attempted to be pulled out but was not successful.For this reason, an unspecified 014-inch guidewire was tried to insert in the side of the burr, but the guidewire was unable to pass through.After that, the drive shaft, drive shaft sheath and the rotawire were cut by the proximal part of the advancer, and then the drive shaft sheath was then removed.However, it was noted that the rotawire and drive shaft sheath became separated with the drive shaft inside the guiding catheter upon removal; the reason for this separation was unknown.An unspecified 7f guiding catheter was additionally inserted, and after inserting the unspecified 014-inch guidewire in the rota burr side with a double guiding catheter, the burr that became stuck was dilated with an unspecified 2.00 diameter balloon.After that, a snare was advanced to try and retrieve but was not successful.For this reason, several unspecified 014-inch guidewires were inserted inside the 8f guiding catheter; after passing through the side of the rota burr and entangling the guidewire, the burr was released and flowed into the aorta.The rotaburr was successfully retrieved by the snare.During retrieval, the burr and a part of the wire were retrieved, however there was a concern that the devices were mistakenly lost during the removal process.Therefore there is a possibility that the rotaburr and a part of the rotawire was left inside of the patient's body.Observation via ct was performed and patient still under follow-up observation.The procedure was not completed due to this event.No other patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the drive shaft, drive shaft sheath and rotawire were cut near the advancer, the drive shaft sheath was then attempted to be removed.No further patient complications were reported.

Event Description

Same case as mdr id: 2134265-2018-05661.It was reported that the burr became stuck in lesion and rotaburr and rotawire device separation occurred.It is possible that the separated pieces remained inside of the patient¿s body.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 2.00mm rotalink¿ plus and a 330cm rotawire¿ and wireclip¿ torquer were selected for use for the percutaneous coronary intervention (pci).An unspecified 8fr sheath and an 8fr mach1 guiding catheter were used during the procedure.After pre-dilatation was done using an unspecified balloon on the lesion area, ablation was performed using the 2.00mm rotalink plus.After several ablations were performed, the burr was passed through the lesion.However, when ablation was performed again, it was noted that the burr became stuck in the lesion area.The burr was attempted to be pulled out but was not successful.For this reason, an unspecified 014-inch guidewire was tried to insert in the side of the burr, but the guidewire was unable to pass through.After that, the drive shaft, drive shaft sheath and the rotawire were cut by the proximal part of the advancer, and then the drive shaft sheath was then removed.However, it was noted that the rotawire and drive shaft sheath became separated with the drive shaft inside the guiding catheter upon removal; the reason for this separation was unknown.An unspecified 7f guiding catheter was additionally inserted, and after inserting the unspecified 014-inch guidewire in the rota burr side with a double guiding catheter, the burr that became stuck was dilated with an unspecified 2.00 diameter balloon.After that, a snare was advanced to try and retrieve but was not successful.For this reason, several unspecified 014-inch guidewires were inserted inside the 8f guiding catheter; after passing through the side of the rota burr and entangling the guidewire, the burr was released and flowed into the aorta.The rotaburr was successfully retrieved by the snare.During retrieval, the burr and a part of the wire were retrieved, however there was a concern that the devices were mistakenly lost during the removal process.Therefore there is a possibility that the rotaburr and a part of the rotawire was left inside of the patient's body.Observation via ct was performed and patient still under follow-up observation.The procedure was not completed due to this event.No other patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The unit returned is stuck inside of the rotablator and broken as part of overall visual revision.Visual inspection revealed that the device returned stuck in the rotablator, with approximately 137cm of the wire coming out from the back side of the rotablator.There is a kink on the body of the device, approximately at 116cm from its proximal end.The rotawire is cut even so the section where the cut was made is not visible.A section of the rotawire of approximately 134cm was returned inside the drive shaft sheath of the other device.At one of its ends is possible to observe evidence of rotational wear and a breakage on this section.Also stuck on this same area is possible to observe a smaller section of the wire /approximately 7cm), where at one of its ends is possible to see a breakage section and evidence of rotational wear, there is also evidence of a breakage on its other end.Together with the wire and the rotablator 2 unknown catheters were returned.Dimensional inspection of the device revealed that the outer diameter (od) of middle of the device and od of proximal section were within specifications.However, the dimensional inspection of the overall length and od of distal tip could not be performed because of the device condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7638162
• MDR Text Key: 112337428
• Report Number: 2134265-2018-05662
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 21220834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 08/13/2018
• Supplement Dates FDA Received: 07/26/2018; 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention