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

Catalog Number	KCFW-8.0-38-40-RB-BLKN
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a procedure, the flexor balkin guiding sheath valve became loose and could not be used.The sheath was placed in the patient's torso; the patient's anatomy was reported as normal.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Attempts for patient and procedural information were made; however no information was able to be obtained.510(k): preamendment.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The sheath and the dilator of the flexor balkin guiding sheath were returned for investigation.The dilator was not inserted through the sheath.The sheath proximal fitting was separated from the sheath tubing.The flare passes the large as well as the small lumen of the flare gauge since it appears to be collapsed.The connector cap was within specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement, each sheath is 100% inspected and verified prior to release.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.In addition, there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7072842
• Report Number: 1820334-2017-04251
• Device Sequence Number: 19282152
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)200414(10)7831782
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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-8.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1