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

Model Number	G09809
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during an anterograde percutaneous transluminal angioplasty (pta) below the knee (btk) with a drug-eluting balloon (deb), the flexor introducer was inserted without difficulty.Another manufacturer's three (3) millimeter (mm) diameter, 120 mm length balloon catheter was advanced over a wire guide (other manufacturer).The balloon catheter utilized has a protective sleeve over the drug-coated balloon; the balloon was required to be inserted into the introducer with the sleeve.As the physician pulled the sleeve from the introducer with the balloon still in place, the elastic portion on the introducer valve did not close and blood spurted out.The physician exchanged the introducer with another flexor introducer and was able to successfully complete the procedure.It was noted that another manufacturer's 0.035 inch diameter wire guide was utilized through the sheath prior to use of the balloon catheter and aforementioned wire guide.According to the initial reporter, the procedure took longer; however, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), 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 that, although the disc was positioned correctly and the fittings were secure, a tear was observed in the silicone disc.A leak test was then performed by occluding the tubing of the sheath with hemostats, and then injecting water through the side-arm using a 20 cc syringe.Leakage was detected through the tear in the silicone disc.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 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.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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 INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7240802
• Report Number: 1820334-2018-00339
• Device Sequence Number: 16433565
• Product Code: DYB
• UDI-Device Identifier: 00827002098091
• UDI-Public: (01)00827002098091(17)200829(10)8179726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142829
• 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,Followup
• Report Date (Section B): 03/24/2020

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: 08/29/2020
• Device Model Number: G09809
• Device Catalogue Number: KCFW-6.0-38-45-RB
• Device Lot Number: 8179726
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/03/2018; 03/24/2020
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 04/04/2018; 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1