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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
An international customer reported that when the physician opened the package, it was noted that the dilator was broken; the two parts of the dilator were separated.The event occurred prior to patient contact.
Additional Manufacturer Narrative
Brief description: dilator broken - prior to pt contact.Description of event: as reported to customer relations: "when the physician opened the package, they note that the dilator is broken, the two parts of the dilator are separated." investigation - evaluation : a review of documentation, dimensional verification, complaint history, device history record, drawings, instructions for use (ifu), manufacturing instructions, quality control data, and visual inspection of the returned device was conducted during the investigation.One performer mullins guiding sheath was returned for investigation.The hub was separated from the dilator.The flare appeared to be out of round.The flare could have been damaged when the hub separated from the sheath, possibly during shipping and handling.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.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.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: 6791414
• Report Number: 1820334-2017-02112
• Device Sequence Number: 1115837
• Product Code: DYB
• UDI-Device Identifier: 00827002091023
• UDI-Public: (01)00827002091023(17)190614(10)7042800
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 08/23/2017

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: N/A
• Device Catalogue Number: RCFW-14.0-38-85-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1