MAUDE Adverse Event Report: IMPRESS PERIPHERAL CATHETER; PERIPHERAL CATHETER,

Catalog Number	410038VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous transluminal angioplasty [pta] procedure for a peripheral chronic total occlusion [cto], the catheter tip detached.The physician had acquired retrograde arterial access and during catheter manipulations within the vessel, the catheter tip detached.The physician used a vascular snare device to successfully retrieve the foreign bodies from the patient.Another sheath was placed to successfully complete the procedure.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.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 PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER,
• MDR Report Key: 10370760
• Report Number: 3010665433-2020-00026
• Device Sequence Number: 3001626
• Product Code: DQO
• UDI-Device Identifier: 00884450020043
• UDI-Public: 0884450020043
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 07/16/2020

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: 11/30/2022
• Device Catalogue Number: 410038VER
• Device Lot Number: E1735606
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 10/27/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention