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

Model Number	G56222
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter: customer name and address= (b)(6).Occupation = distributor.Pma/510(k) number = pre-amendment.Device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.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
As originally reported, prior to patient contact during a peripheral angiogram, the flexor high-flex ansel guiding sheath would not advance over an unknown "zip" wire guide.Damage to the tip of the device was reported.Upon return and initial evaluation of the device on 26nov2019, the tip of the device was noted to be split.The complaint device did not make contact with 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.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one flexor high-flex ansel guiding sheath was returned to cook for investigation.Biomatter was present on the tip and hub of the device.It was noted that the proximal fitting of the sheath was crooked, which likely occurred during transit from the user facility to the manufacturer.The sheath tip was split.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 manufacturer¿s instructions.Drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which notes ¿upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided and the examination of the returned product, investigation has concluded that this event could not be traced to the device, but several other possible causes were noted.Those possibilities include shipping, storage, user handling, as well as patient condition or the type of procedure being performed.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.
Additional Manufacturer Narrative
Summary of event: as originally reported, prior to patient contact during a peripheral angiogram, the flexor high-flex ansel guiding sheath would not advance over an unknown "zip" wire guide.Damage to the tip of the device was reported.The complaint device did not make contact with the patient's body.Corrected information: 510k= k142829.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one flexor high-flex ansel guiding sheath was returned to cook for investigation.Biomatter was present on the tip and hub of the device.It was noted that the proximal fitting of the sheath was crooked, which likely occurred during transit from the user facility to the manufacturer.The sheath tip was split.Additionally, a document-based investigation evaluation was performed.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 manufacturer¿s instructions.Drawing, and quality control procedures were conducted, and no gaps were discovered.There is evidence to support that the device was manufactured to specification and that items in the lot or similar devices in the field or in house were built to specification.An ifu is provided with this device, which notes ¿upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided and the examination of the returned product, investigation has concluded that this event could not be traced to the device.Possible causes for the device failure include shipping, storage, user handling, as well as patient condition or the type of procedure being performed.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 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: 9401900
• Report Number: 1820334-2019-03001
• Device Sequence Number: 2230575
• Product Code: DYB
• UDI-Device Identifier: 00827002562226
• UDI-Public: (01)00827002562226(17)220509(10)9727771
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2020

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: 05/09/2022
• Device Model Number: G56222
• Device Catalogue Number: KCFW-7.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9727771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 03/06/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/21/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1