MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) FIGHTER; CATHETER, GUIDEWIRE

Model Number	H749393031902
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that tip detachment inside the patient occurred.Vascular access was obtained via an antegrade approach.The ambiguous cap lesion was located in the calcified, chronic total occlusion right coronary artery (rca).A 190cm fighter guidewire was engaged to the lesion.The physician attempted to "knuckle" the guidewire very aggressively with a non-bsc catheter for support.The tip of the guidewire detached and remained in the mid rca.The rest of the wire was removed from the body.The detached tip was attempted to be removed with the support of a 2.5x20mm emerge balloon catheter without success.A 3.5x15 nc emerge was inflated at the mid rca where the fighter was located and a 3.5x38 synergy drug-eluting stent was deployed over the broken fighter tip.It appeared that the synergy stent completely "trapped" the wire tip against the vessel wall as there were no luminal irregularities in the post images.At the end of the case the patient is in stable condition.
Additional Manufacturer Narrative
Device evaluated by mfr: the examination of the returned product revealed that both, the coil and the corewire were severed at approximately 36mm from the distal tip and the distal portion of the wire was missing.Also, the corewire proximal to the breakage point was necked and had become thinner with evidence of kinking.The fracture surface showed a dimple pattern characteristic of a ductile fracture.A length of the wire from approximately 9mm from the fracture site was deformed into a semicircular shape and pitch deviation of the coil was confirmed in several locations.Thus, it is estimated that approximately 36mm of the core / coil portion remained in the patient.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that tip detachment inside the patient occurred.Vascular access was obtained via an antegrade approach.The ambiguous cap lesion was located in the calcified, chronic total occlusion right coronary artery (rca).A 190cm fighter guidewire was engaged to the lesion.The physician attempted to "knuckle" the guidewire very aggressively with a non-bsc catheter for support.The tip of the guidewire detached and remained in the mid rca.The rest of the wire was removed from the body.The detached tip was attempted to be removed with the support of a 2.5x20mm emerge balloon catheter without success.A 3.5x15 nc emerge was inflated at the mid rca where the fighter was located and a 3.5x38 synergy drug-eluting stent was deployed over the broken fighter tip.It appeared that the synergy stent completely "trapped" the wire tip against the vessel wall as there were no luminal irregularities in the post images.At the end of the case the patient is in stable condition.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6121132
• Report Number: 2134265-2016-10435
• Device Sequence Number: 16326521
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: (01)08714729886617(17)20161206(10)19346399
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2016

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 Expiration Date: 12/06/2016
• Device Model Number: H749393031902
• Device Lot Number: 19346399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 02/07/2017
• 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: TURNPIKE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention