MAUDE Adverse Event Report: MEDCOMP 13.5FX20CM SIL DBL LMN W/STYLE; HEMO-CATH ST

Model Number SDL138E

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

A.035" x 70cm "j" marked guidewire was returned.Visual inspection of the returned device revealed the guidewire is unraveled at the distal end.Device forwarded to the device contract manufacturer for evaluation.

Event Description

Catheter went the wrong way with insertion up towards the head.When attempting to pull it back the guidewire frayed.

Manufacturer Narrative

As this is a purchased device the sample was forwarded to the device contract manufacturer for review.The record review showed the device was manufactured per specification.No non-conformances or anomalies were noted during manufacturing.It was not possible to make a definitive determination of the root cause of this issue based on the evidence presented by the sample provided and the information provided.

• Brand Name: 13.5FX20CM SIL DBL LMN W/STYLE
• Type of Device: HEMO-CATH ST
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8594835
• MDR Text Key: 144971945
• Report Number: 2518902-2019-00032
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908042351
• UDI-Public: 884908042351
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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?: No
• Device Operator: Other
• Device Expiration Date: 08/28/2023
• Device Model Number: SDL138E
• Device Catalogue Number: SDL138E
• Device Lot Number: MLND080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1