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

Model Number	2781
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the guidewire broke and a piece remained inside the patient.A 300cm pt2 guidewire was selected for use for a procedure in the lower leg.The patient had grade 4 calcification on the lower leg.The wire broke as the doctor passed the stenosis.The piece of wire remained in the patient and could not be recovered.According to the physician, the strong calcification was to blame for breaking the wire.
Event or Problem Description
It was reported that the guidewire broke and a piece remained inside the patient.A 300cm pt2 guidewire was selected for use for a procedure in the lower leg.The patient had grade 4 calcification on the lower leg.The wire broke as the doctor passed the stenosis.The piece of wire remained in the patient and could not be recovered.According to the physician, the strong calcification was to blame for breaking the wire.
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: analysis of returned product revealed that the device is broken at the distal section.Only 298.5 cm was returned.Also the distal end is kinked at the broken section.

• 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: 8146314
• Report Number: 2134265-2018-63655
• Device Sequence Number: 2118432
• Product Code: DQX
• UDI-Device Identifier: 08714729471257
• UDI-Public: 08714729471257
• 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): 02/05/2019

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: 06/12/2020
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0022246229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: Other