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

Model Number	40295
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring intervention.A.018/260cm platinum plus - pi guidewire was selected for use in the left superficial femoral artery (sfa).However, the wire tip came off in the patient's body.The physician gained a second access site (left pedal artery) and used a balloon and snare technique to retrieve the wire tip.There were no additional patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred requiring intervention.A.018/260cm platinum plus - pi guidewire was selected for use in the left superficial femoral artery (sfa).However, the wire tip came off in the patient's body.The physician gained a second access site (left pedal artery) and used a balloon and snare technique to retrieve the wire tip.There were no additional patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch.The unit returned has the wire tip damaged, as part of overall visual revision.It is possible to observe that the spring tip is highly damaged, the corewire is broken (2 parts separated) and else the spring tip is stretched & unraveled.Besides, detached tip is bent.It is possible to observe that the spring tip is highly damaged, the corewire is broken (2 parts separated) and else the spring tip is stretched & unraveled.Besides, detached tip is bent and has residues that looks like dried blood.The customer did provide a picture related to the complaint where is possible to observe that the spring tip is unraveled.All od dimensions were found within specification.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10402386
• Report Number: 2134265-2020-10892
• Device Sequence Number: 16917636
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• 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): 09/23/2020

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: 09/04/2022
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0024381514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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