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

Model Number	G10385
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a percutaneous transluminal angioplasty (pta), a flexor balkin guiding sheath separated at the hub.Access was obtained in the right femoral artery for advancement into the left iliac artery.It was reported that the 8fr complaint device was inserted and felt "too tight".While exchanging the device with an unknown 6fr sheath, the complaint device separated at the hub.The procedure was completed with the unknown 6fr sheath.The patient was reported to be stable, with discharge planned.The outcome was reported as "good".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.Reviews of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one kcfw-8.0-38-40-rb-blkn was returned with the dilator inserted into the proximal end of the sheath tubing.The sheath proximal fitting was separated.There was no visible biomatter on the device.The flare was wrinkled, and the edges were folded inward.The sheath tip appeared slightly out of round.There was no visible damage to the sheath tubing or dilator.The outer threads of the connector cap were damaged, possibly from hemostats.The connector cap inner diameter measured within specification, and the flare also gauged within specification.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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ based on the information provided and the examination of the returned product, investigation has concluded that this event cannot be traced to the device.Instead, as the physician was exchanging the complaint sheath for a smaller size because it was too large for the vessel, it is likely that the tight fit between the vessel and the cook sheath contributed to the device failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8275014
• Report Number: 1820334-2019-00186
• Device Sequence Number: 138074
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)190824(10)7222829
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2020

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: 08/24/2019
• Device Model Number: G10385
• Device Catalogue Number: KCFW-8.0-38-40-RB-BLKN
• Device Lot Number: 7222829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/29/2019; 03/20/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/03/2019; 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 65