MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned guidewire was inspected and a section with jumped coils were found; it was located approximately at 64 cm from the proximal end.The coating of the damaged section was peeled.No more damages were found in the returned device.The overall length, the overall diameter of distal tip, the middle of the device and the proximal section was measured within specification.
Event or Problem Description
Reportable based on device analysis completed on 24-jan-2020.It was reported that guidewire resistance occurred.The target lesion was located in the right subclavian vein.A 035/180/3mm amplatz super stiff guidewire was selected for use.After flushing the wire inside it's sheath the wire was difficult to withdraw.A 14x6cm xxl balloon catheter was advanced but the wire got stuck inside it, and so it was removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed coating peeled/sheared.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9699201
• Report Number: 2134265-2020-01265
• Device Sequence Number: 19259665
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: 08714729295648
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0021186202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 50