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

Model Number	2480
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date as best estimate as there was no information provided.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the calcified obtuse marginal (om).A choice graphix pt intermediate guidewire was used; however, during removal, a piece of the tip broke off in the om.The physician made several attempts to snare the fractured portion but was unable to reach it.The physician decided to leave the fractured portion in the om as here was no fear of patient harm.No patient complications were reported and the patient was fully recovered.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the calcified obtuse marginal (om).A choice graphix pt intermediate guidewire was used; however, during removal, a piece of the tip broke off in the om.The physician made several attempts to snare the fractured portion but was unable to reach it.The physician decided to leave the fractured portion in the om as here was no fear of patient harm.No patient complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
B2.Date of event: used the first day of the month of the aware date as best estimate as there was no information provided.Device evaluated by mfr.: unit returned with its original pouch batch 24578592.The returned device matches with upn and lot provided by the customer.The returned guidewires spring tip was bent/kink and unraveled.The guidewire had a kink at 0.5" section from the proximal end, and also at the 35" section from the proximal end.The device was measured in three sections (distal - medium - proximal) all were within specification.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12511037
• Report Number: 2134265-2021-11321
• Device Sequence Number: 3913455
• Product Code: DQX
• UDI-Device Identifier: 08714729141723
• UDI-Public: 08714729141723
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 10/09/2021
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0024578592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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; Required Intervention