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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 tibial intervention using a flexor shuttle tibial guiding sheath the tuohy was leaking.It is specifically not leaking on the 3 way stop cock side.It is leaking where the clear plastic tubing is connected to the white hub.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no reported adverse effects caused or contributed to the product.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, quality control, personnel interview, visual inspection and functional testing of the returned device was conducted during the investigation.A document-based investigation was also performed.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.Only the sheath connecting tube subassembly of the complaint flexor shuttle tibial guiding sheath device was returned for inspection.A leak test was performed on the subassembly, and leakage was detected where the white fitting (connector cap) is connected to the clear tubing.The two white fittings (connector cap and pmlla) were disassembled from the connecting tube for further examination.A hole was found in the clear tubing just below the flare.It is possible that this damage could have occurred during the flaring manufacturing process.The connecting tube subassembly is supplied to cook by (b)(4).(b)(4) does not currently have a validated process for manufacturing the connecting tube subassembly.The compliance issue of lack of verification or validation will be addressed.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause was determined to most likely be related to the manufacturing process.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6684081
• Report Number: 1820334-2017-00858
• Device Sequence Number: 13923851
• Product Code: DYB
• UDI-Device Identifier: 00827002481909
• UDI-Public: (01)00827002481909(17)200209(10)7662632
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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: KSAW-4.0-18/35-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1