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

Model Number H802228240022

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the rotawire tip was detached and remained inside patient's body.The target lesion was located in the severely calcified mid left anterior descending artery.A 330cm rotawire¿ was selected for use.During procedure, a 8f non-bsc guide catheter was engaged in the ostium of left coronary artery.A 0.014 guidewire and microcatheter were advanced and crossed the lesion and was then replaced with the rotawire.The rotawire was advanced inside the guide catheter towards in order to reach the rotalink plus 1.75mm up to lesion area by dynaglide, a movement in the rotawire tip was noted.The rotawire was then pulled slightly and noted that the tip part of the wire detached as it did not moved.The detached tip was snared, however the tip migrated to the distal part of the blood vessel and was unable to be retrieved.The procedure was completed with another of the same device.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the returned device revealed that the distal tip was stretched and a section of it is detached (this section was not returned); the broken section is located approximately at 329 cm from the proximal end; besides, the body of the guidewire is kinked approximately at 324.8 cm from the proximal end.Dimensional inspection were performed and observed that the outer diameter (od) of the middle of the device and od of the proximal section were within specification.However, the overall length and od of the distal tip could not be performed due to the device condition.A section of the distal tip was sent for further imaging; the obtained results are the following: rotawire tip presented a brittle fracture produced by fatigue and rotational bending mechanical overload.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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the rotawire tip was detached and remained inside patient's body.The target lesion was located in the severely calcified mid left anterior descending artery.A 330cm rotawire was selected for use.During procedure, a 8f non-bsc guide catheter was engaged in the ostium of left coronary artery.A 0.014 guidewire and microcatheter were advanced and crossed the lesion and was then replaced with the rotawire.The rotawire was advanced inside the guide catheter towards in order to reach the rotalink plus 1.75mm up to lesion area by dynaglide, a movement in the rotawire tip was noted.The rotawire was then pulled slightly and noted that the tip part of the wire detached as it did not moved.The detached tip was snared, however the tip migrated to the distal part of the blood vessel and was unable to be retrieved.The procedure was completed with another of the same device.No further patient complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7138243
• MDR Text Key: 95499773
• Report Number: 2134265-2017-12697
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: 09/04/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0021091852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER- 8F MACH1 Q4 SH
• Patient Outcome(s): Required Intervention