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

Catalog Number	510035BER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges during a peripheral vascular selective abdominal angiogram [third order] of the lower abdominal extremities for deployment of a right renal artery stent, when the catheter tip kinked and detached.The physician had acquired open unilateral subclavian artery access for delivery of endovascular prosthesis [stent] via infraclavicular or supraclavicular incision.A 12f sheath was successfully placed.Through the 12f sheath a steerable sheath was placed and a 100 cm 5f diagnostic catheter was introduced.The physician states that a significant amount of torque was placed on the steerable sheath when it kinked.When the physician tried to remove the diagnostic catheter the first 12-20 cm detached at the kink and remained within the steerable sheath.The steerable sheath was removed together with the catheter tip and passed off the sterile field.The patient tolerated the procedure well.No patient injury 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.Should the device return at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®.BRAIDED.CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11013421
• Report Number: 3010665433-2020-00055
• Device Sequence Number: 2684761
• Product Code: DQO
• UDI-Device Identifier: 00884450009253
• UDI-Public: 884450009253
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 07/07/2023
• Device Catalogue Number: 510035BER
• Device Lot Number: E1870319
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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: NEGARE STEERABLE SHEATH -TERUMO; NEGARE STEERABLE SHEATH -TERUMO