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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a cross over access for atherectomy procedure using a flexor balkin guiding sheath, when an attempt was made to retrieve the introducer, the valve separated from the sheath.When this was noticed, a clamp was used to hold the sheath at the distal end preventing the introducer from slipping into the puncture hole.Everything was retrieved together.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
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.A flexor balkin guiding sheath was returned for investigation with the proximal fitting (check-flo) separated from the shaft of the sheath.Multiple hemostat/clamp marks were observed on the sheath tubing just distal to the flare.The flare was distorted (oval-shaped), which could be attributed to the use of a hemostat/clamp.The flare passed through the large hole and did not pass through the small hole; therefore, the flare passed the flare gauge test.The inner diameter (id) of the connector cap was measured using pin gauges.The connector cap was found to easily accept the 0.152" pin gauge, but not the 0.153" gauge.Therefore, the connector cap id was within specification.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.The flexor sheath was used for treatment of peripheral arterial vascular disease, and the separation of the proximal fitting was noted to occur during removal of the device.It was determined that the sheath could have been forced through restrictive anatomy, thus causing separation upon removal.Per the health risk assessment, no further action is warranted.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: 6684312
• Report Number: 1820334-2017-01495
• Device Sequence Number: 56943
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)200215(10)7678794
• 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): 09/15/2017

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: KCFW-8.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1