MAUDE Adverse Event Report: COVIDIEN 3570 KENGUARD SILCATH 5CC 24FR; CATHETER, UROLOGICAL

Model Number	3570-
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); High Blood Pressure/ Hypertension (1908); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it is still in use therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the catheter was inserted on (b)(6) 2021.He began taking oxybutynin 5mg in the morning and evening but is having regular episodes of autonomic dysreflexia (ad), 3 or 4 per hour, but they were not as severe on (b)(6) 2021.However, the night of (b)(6) 2021 his blood pressure was 212/106 with a pulse of 43 during a five minute ad episode before going to bed, i.E.One day of oxybutynin was not enough to help.The customer further stated that this catheter expired in 2018 which he was aware of prior to insertion.He confirmed that the catheter is draining.Additional information provided by the customer on 7-apr-2021 stated that the catheter is still in use and he has had no further issues, (b)(6) 2021 was the last day he took oxybutynin.

• Brand Name: 3570 KENGUARD SILCATH 5CC 24FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• MDR Report Key: 11691146
• Report Number: 9611712-2021-00108
• Device Sequence Number: 16924434
• Product Code: KOD
• UDI-Device Identifier: 20884521016740
• UDI-Public: 20884521016740
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 3570-
• Device Catalogue Number: 3570-
• Device Lot Number: 3345133QX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1