MAUDE Adverse Event Report: COOK INC FLEXOR RTPS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-9.0-35-38.5-RB-RTPS-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a transjugular liver biopsy, upon injecting contrast, the tube detached from the hub (approximately 5cc contrast).A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Evaluation- a review of the complaint history, device history record, quality control, trends, and a visual inspection were conducted during the investigation of this event.One kcfw-9.0-35-38.5-rb-rtps-100 sheath was returned for evaluation with the connecting tube separated from the check-flo body.Upon investigation of the returned product, very little adhesive residue was found on the connecting tubing and no residue had been observed on interior of the check-flo body sidearm.It is likely that the failure mode was attributed to there not being enough adhesive used during the manufacturing process.The appropriate personnel will be notified.We will continue to monitor for similar events.

• Brand Name: FLEXOR RTPS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5535022
• Report Number: 1820334-2016-00181
• Device Sequence Number: 11010239
• Product Code: DYB
• UDI-Device Identifier: 00827002131606
• UDI-Public: (01)00827002131606(17)190111(10)6509739
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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 Catalogue Number: KCFW-9.0-35-38.5-RB-RTPS-100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 03/09/2017
• 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: Other