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

Model Number	G29989
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
(b)(4).Pma/510(k) number: pre-amendment.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
It was reported that at the end of a subclavian stenting procedure, the physician noted there was a leak of the tubing at the side of the flexor ansel guiding sheath; percutaneous transluminal angioplasty (tpa) balloon and stents were being utilized through the complaint device at the time.Reportedly the sheath was working fine and the physician completed the procedure with the complaint device.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 dimensional verification, complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a small hole in the stopcock, at the interface between it and the syringe.At the start of the leak test, water passed through the hole, and minimal water was able to pass through the connecting tube.Eventually, water passed through the connecting tube and into the sheath, but with air bubbles and without a continuous flow, on account of the continual water leak.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted that there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7503092
• Report Number: 1820334-2018-01298
• Device Sequence Number: 2018337
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)190222(10)6752284
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2020

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 Model Number: G29989
• Device Catalogue Number: KCFW-6.0-18/38-90-RB-ANL1-HC
• Device Lot Number: 6752284
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 03/26/2020
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/07/2018; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PTA BALLOON AND STENTS