MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888221320
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, they attempted to pull the wire, but they felt a resistance, and as they were pulling, the guide wire was stretched out, so they stopped and pulled the wire and the catheter, they examined the tip of the wire and catheter and they were both intact but noted that the wire was stretched a bit.Xray was done to check if foreign body was left and nothing was seen.A new catheter was inserted without any issues.
Event or Problem Description
According to the reporter, intra-operatively, they attempted to pull the wire but they felt a resistance, and as they were pulling, the guide wire was stretched out, so they stopped and pulled the wire and the catheter, they examined the tip of the wire and catheter and they were both intact but noted that the wire was stretched a bit and was frayed.Xray was done to check if foreign body was left and nothing was seen.It was stated that the guide wire provided with the kit was used.A new catheter was inserted without any issues.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted that the guide wire was stretched and frayed.The catheter appeared intact.A functional evaluation found that the catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur with improper handling during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8208402
• Report Number: 3009211636-2019-00001
• Device Sequence Number: 264251
• Product Code: MPB
• UDI-Device Identifier: 20884521126388
• UDI-Public: 20884521126388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2019

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 Model Number: 8888221320
• Device Catalogue Number: 8888221320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/29/2019; 03/12/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/25/2019; 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention