MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; DIAGNOSTIC CATHETER

Catalog Number	510038VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges during a percutaneous transluminal angioplasty [pta] procedure, the catheter tip detached within the patient.The foreign body migrated further into the patient's artery.The physician attempted to retrieve the foreign body from the patient without success.The patient is scheduled for surgical removal of the foreign body.
Additional Manufacturer Narrative
Part of the suspect device was returned for investigation.The tip of the catheter was not received to investigate therefore examination was conducted on only the shaft of the returned device.The device was examined visually and microscopically.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: DIAGNOSTIC CATHETER
• MDR Report Key: 11233425
• Report Number: 3010665433-2021-00006
• Device Sequence Number: 4103945
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: 884450009222
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 08/09/2023
• Device Catalogue Number: 510038VER
• Device Lot Number: E1924498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention