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

Model Number	G08308
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.
Event or Problem Description
The dilator tip of the mullin sheath was found defected when taken out from packaging.According to the reporter the dilator tip was kinked and the edge appeared not as smooth as the normal.No patient contact was reported regarding the device.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, quality control, inspection of unused product, and visual inspection of the returned device was conducted during the investigation.The sheath and dilator of the performer mullins guiding sheath were returned.The dilator was returned inserted into the sheath and clear fluid was present in the side arm.What appears to be biologic matter was on the side arm.A 1mm wrinkle is noted on the dilator distal tip.A compression is noted 1mm from the dilator distal tip.A kink is noted 2.4cm from the proximal hub of the dilator.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Since this device is inspected 100% for defects prior to transport, it is plausible to suggest that the described damage is a result of vigorous handling during the transport process.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6638204
• Report Number: 1820334-2017-01558
• Device Sequence Number: 10785758
• Product Code: DYB
• UDI-Device Identifier: 00827002083080
• UDI-Public: (01)00827002083080(17)180411(10)5797641
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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 Model Number: G08308
• Device Catalogue Number: RCFW-6.0-38-63-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1