MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	510038SIM2/CN
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2021
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 during a procedure the angiography tube broke into 2 sections.While attempting to remove the foreign bodies they broke again for a total of 4 pieces.An additional procedure was necessary to repair damage to the patient vasculature after removal of the pieces.There is no further patient consequence to report.
Additional Manufacturer Narrative
The suspect device was not returned 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.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 12134877
• Report Number: 3010665433-2021-00049
• Device Sequence Number: 20058173
• Product Code: DQO
• UDI-Device Identifier: 00884450009307
• UDI-Public: 884450009307
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N/A
• 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): 06/25/2021

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: 01/31/2022
• Device Catalogue Number: 510038SIM2/CN
• Device Lot Number: E1502935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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: Hospitalization; Life Threatening; Required Intervention