MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number	RCFW-18.0P-38-30-RB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info) unknown as not provided.Health professional?) unknown as not provided.Occupation) unknown as not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
The valve torn apart from the introducer while administering the contrast media.The user facility changed the introducer and continued with the procedure.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, device record history, specification, quality control and a visual inspection of the returned device was conducted during the investigation.The consumer stated the valve was torn apart from the introducer during removal.The consumer was contacted for clarification and reported that upon administration, the contrast agent suddenly dissolved the entire white tube from the actual introducer.The device history record was reviewed and no non-conformances were noted.A search revealed this complaint to be the only reported complaint associated to the complaint lot number 6536115.One used performer introducer sheath was returned with the hub and sheath in tact.The visual inspection reported the connecting tube had separated from the side arm, and was not returned for the investigation.Upon visual inspection of the returned device, little to no adhesive residue was found at the side arm connection.However, since the connecting tube was not returned as well, it could not be inspected for the presence of adhesive residue.Without being able to inspect the connecting tube the root cause could not be confirmed.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
The valve torn apart from the introducer while administering the contrast media.The user facility changed the introducer and continued with the procedure.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5673173
• Report Number: 1820334-2016-00335
• Device Sequence Number: 49427
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)190223(10)6536115
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2016

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: RCFW-18.0P-38-30-RB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 08/19/2016
• 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