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

Model Number	G32194
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: unspecified guide wire, bard lutonix dcb, mpis kit.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, during an unspecified procedure to treat the calcified left common femoral artery, via groin access, an "ansel sheath" became uncoiled and the hub separated when the 7x60 drug coated balloon (dcb) was being pulled out of the patient's anatomy.Resistance was felt.The sheath was in place approximately twenty minutes.The top came out.No part of the device remained in the patient's anatomy.No blood loss occurred as a result of this event.The patient did not experience adverse effects or require any additional procedures as a result of this occurrence.The patient is described as being "fine".Additional information provided the dilator was not in place when the separation occurred.The sheath and dilator were not withdrawn as a unit nor was a wire guide or other devices in the lumen of the sheath when the separation occurred.The sheath hub was not used to remove the sheath from the patient.The complainant confirmed the complaint device was a flexor introducer sheath.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, images were provided of the complaint device and it was confirmed that the sheath tubing had separated during removal from the patient.The inner coiling had become exposed from the interior of the sheath and elongated in multiple regions.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 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, reviews of the manufacturer¿s instructions, drawings, instructions for use, specifications, and quality control procedures were conducted, and no gaps were discovered.Through these reviews, cook confirmed that adequate controls are in place to prevent this type of failure mode.Based on the information provided and no product returned, investigation has concluded that a root cause cannot be determined at this time with the given information.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.Corrected information: g5.
Event or Problem Description
No new patient or event information received since the last report was submitted.

• 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: 8367463
• Report Number: 1820334-2019-00419
• Device Sequence Number: 1346091
• Product Code: DYB
• UDI-Device Identifier: 00827002321946
• UDI-Public: (01)00827002321946(17)211102(10)9283671
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

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: 11/02/2021
• Device Model Number: G32194
• Device Catalogue Number: KCFW-5.0-38-30-RB
• Device Lot Number: 9283671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 03/17/2020
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/29/2019; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1