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

Model Number	G47701
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	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.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 inferior vena cava (ivc) filter retrieval procedure, the hub of the dilator provided with the flexor high-flex ansel guiding sheath disconnected.According to the initial reporter, access was gained via the right internal jugular vein.The sheath and dilator were being advanced together over an unspecified 0.035" wire guide.The patient's anatomy was not described as tortuous or calcified; however, as the dilator was being removed over the wire guide, it was reported that it was being removed by hub.It was during the removal that the hub separated.The unspecified filter device was able to be retrieved, and the procedure was completed successfully.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.
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
Investigation evaluation: a review of the dimensional verification, complaint history, device history record, 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 used kcfw-12.0-35-45-rb-hfanl1-hc dilator was returned without the sheath.There was visible biomatter throughout the device.The proximal fitting was separated and also returned.There was no damage to the dilator shaft.The proximal flare was intact and in round, but was wrinkled and damaged from use.The dilator outer diameter was measured at various locations on the shaft and raged from.159-.161¿ depending on the location and rotation of the dilator.The flla and mlla fittings were separated and when the dilator was inserted proximally through the mlla fitting, the flare sat on the cap, but could not be pulled through.The mlla cap was pin gauged and the inner diameter measured 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, a review of the manufactures instructions and quality control procedures was conducted, and undersized flares resulting in inadequate tensile strength at the hub joint were discovered.However, it is unclear if this gap can be directly related to the reported failure.Measures are being conducted to address this failure mode.Based on the information provided, the examination of the returned product, 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
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 HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8053455
• Report Number: 1820334-2018-03238
• Device Sequence Number: 1472843
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)201023(10)8313406
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• 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: 10/23/2020
• Device Model Number: G47701
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Device Lot Number: 8313406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 02/14/2019; 03/17/2020
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 02/18/2019; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED 0.035" WIRE GUIDE