MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2781
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.Vascular access was gained through a retrograde puncture via the dorsalis pedis artery.The target anatomy was located within an artificial vein interposition on the proximal lower leg.The patient had a popliteal bypass with entrapment syndrome within the transition interposition-a.Fibularis on the right.A 300 cm pt2 guidewire was selected to treat stenosis below the right knee.The wire was advanced to the stenosis.The wire tip detached from the wire.The tip remained inside the patient, and the rest of the wire was removed.An interventional attempt was not made to remove the detached wire tip.It was not possible to probe the distal anastomosis bypass for dilation during the procedure.The procedure was ended and the patient had no change in condition.A previously necessary bypass anastomosis revision along with a surgical salvage where the detached tip was retrieved was completed two days later successfully.
Additional Manufacturer Narrative
Device analysis by mfr: the device was returned inside of a hoop together with its original pouch.The polymer tip was detached approximately at 298.3 cm from the proximal end.The detached section was not returned.The distal tip was found slightly bent.No other damage or irregularities were found.
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.Vascular access was gained through a retrograde puncture via the dorsalis pedis artery.The target anatomy was located within an artificial vein interposition on the proximal lower leg.The patient had a popliteal bypass with entrapment syndrome within the transition interposition-a.Fibularis on the right.A 300 cm pt2 guidewire was selected to treat stenosis below the right knee.The wire was advanced to the stenosis.The wire tip detached from the wire.The tip remained inside the patient, and the rest of the wire was removed.An interventional attempt was not made to remove the detached wire tip.It was not possible to probe the distal anastomosis bypass for dilation during the procedure.The procedure was ended and the patient had no change in condition.A previously necessary bypass anastomosis revision along with a surgical salvage where the detached tip was retrieved was completed two days later successfully.It was further reported that the patient was in stable condition after the surgical procedure in which the detached tip was retrieved, and then discharged from the hospital.The physician could not determine if any side effects to the patient were caused by the detached tip.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9218253
• Report Number: 2134265-2019-12745
• Device Sequence Number: 2801326
• Product Code: DQX
• UDI-Device Identifier: 08714729471233
• UDI-Public: 08714729471233
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030617
• 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
• Report Date (Section B): 10/31/2019

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: 07/16/2020
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0022389196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention