MAUDE Adverse Event Report: COOK INC CHECK-FLO EXTRA LARGE INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
While advancing the sheath within the female patient during a aaa procedure, the dilator was damaged during advancement and broke off within the sheath.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.No additional information has been provided.
Additional Manufacturer Narrative
(b)(4).Investigation / evaluation.During the course of investigation, a review of the complaint history, device history record, documentation, manufacturing instructions (mi) and quality control (qc) was conducted.Although we were initially informed the product would be returned for evaluation, as of 16may2016, no product was received.We were further advised that the rep has made 4 requests for additional information regarding this event; however, no response was provided.The device history record was reviewed for the provided lot; and there have been no additional complaints involving this lot.Per quality control specification, the flare must be securely seated in adapter and the tubing must not turn in fittings.In addition, the joints must be secure.Without the benefit of a returned complaint device, a definitive root cause could not be determined.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
While advancing the sheath within the female patient during a aaa procedure, the dilator was damaged during advancement and broke off within the sheath.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.No additional information has been provided.

• Brand Name: CHECK-FLO EXTRA LARGE INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5582274
• Report Number: 1820334-2016-00259
• Device Sequence Number: 16387062
• Product Code: DYB
• UDI-Device Identifier: 00827002289994
• UDI-Public: (01)00827002289994(17)180401(10)5768236
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2016

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 Model Number: N/A
• Device Catalogue Number: XVCFW-20.0-35-25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2016
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2016
• Supplement Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1