MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER STAINLESS STEEL GUIDEWIRE; INTRODUCER, CATHETER

Model Number M001201081

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 Description

It was reported that the tip detached and was snared.The target lesion was located in the fistula.A stainless steel guidewire was selected for use.During procedure, the wire was attempted to put through a 5fr non-bsc micropuncture set.However, when the wire was retracted; it was noted that a portion of the tip broke and sheared off.The detached portion was then retrieved through snare.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr: device analysis revealed that the guidewire was broken.Both sections of the guidewire have several kinks.The distal section was broken, the broken ends show evidence of bending.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).

Event Description

It was reported that the tip detached and was snared.The target lesion was located in the fistula.A stainless steel guidewire was selected for use.During procedure, the wire was attempted to put through a 5fr non-bsc micropuncture set.However, when the wire was retracted; it was noted that a portion of the tip broke and sheared off.The detached portion was then retrieved through snare.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was fine.

• Brand Name: STAINLESS STEEL GUIDEWIRE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7650086
• MDR Text Key: 112716345
• Report Number: 2134265-2018-05868
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K952828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M001201081
• Device Catalogue Number: 20-108
• Device Lot Number: 0018415222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR