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

Model Number	G10384
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	11/11/2018
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, the flexor balkin guiding sheath's valve disconnected upon removal from the patient's anatomy during a lower extremity angiography/angioplasty procedure via a contralateral approach.An unknown manufacturer's dilator was in place through the complaint device at the time of the disconnection.Reportedly, this caused "increased bleeding" in the (b)(6) year old female patient, but blood loss was not quantified, nor was medical intervention performed.The patient did not experience any adverse effects as a result of this occurrence.Additional information regarding event details has been requested but not yet received.According to the customer, the complaint device will not be returned to the manufacturer to aid in the investigation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.B5: the customer provided the following additional information: at the time of disconnection, the complaint device was located in the patient's aorta - iliac bifurcation.The procedure was successfully completed using another flexor balkin guiding sheath.Although requested, information regarding the patient's anatomy was not provided.Additionally, the quantity of blood loss was not provided.Investigation - evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufactures instructions, quality control, and trends of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows 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, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.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
Please see h10.
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.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 BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8310854
• Report Number: 1820334-2019-00236
• Device Sequence Number: 2198311
• Product Code: DYB
• UDI-Device Identifier: 00827002103849
• UDI-Public: (01)00827002103849(17)200404(10)7800570
• 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: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• 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: 04/04/2020
• Device Model Number: G10384
• Device Catalogue Number: KCFW-7.0-38-40-RB-BLKN
• Device Lot Number: 7800570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 03/23/2020
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 02/27/2019; 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: 82 YR