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

Model Number	G08246
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unknown procedure, a flexor introducer sheath leaked "very badly".Additional information has been requested, but is unavailable at this time.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an unknown procedure, a flexor introducer sheath leaked "very badly." investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one 7fr ansel sheath was received used with bio present.No visible damage to device was noted.Leak test confirmed the device leaked from the hole in the silicon disc.The disc was removed from check flo and inspection found the disc was not damage and had been properly cut on the back side.A review of the device history record found one non-conformances related to the reported failure mode.The affected units were scrapped and not replaced.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A capa was previously completed to address this failure mode for valves 10371-se and cfmw-100-se manufactured at seisa, and the capa included a root cause investigation.The capa team examined the valves to test the potential causes identified.Based on the laboratory investigation, a root cause of inadequate tightening of the cap onto the valve body was identified related to leaking around the silicone disk and through the cap.A fixed span gauge that will measure the distance of the cap to the bottom check-flo valves was implemented as a result to ensure that the caps are adequately tightened onto the body of the valves.Based on the evaluation, the cause of this complaint is component failure without design or manufacturing deficiency.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10390950
• Report Number: 1820334-2020-01467
• Device Sequence Number: 2898873
• Product Code: DYB
• UDI-Device Identifier: 00827002082465
• UDI-Public: (01)00827002082465(17)210810(10)9085448
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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 Expiration Date: 08/10/2021
• Device Model Number: G08246
• Device Catalogue Number: KCFW-7.0-38-30-RB
• Device Lot Number: 9085448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1