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

Model Number	G44153
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 reported, during an angioplasty, a flexor ansel guiding sheath "crunched up" upon attempted removal of an unknown balloon through the sheath.When the stuck balloon was unable to be removed from the sheath, the user removed both the balloon and sheath together from the patient.Another sheath was used to complete the procedure.Once the device was removed, the arteriotomy site was larger than anticipated and bleeding was observed, including an expanding hematoma.A 9 french closure device was used to manage the hematoma successfully.The anatomy was not calcified.
Event or Problem Description
Additional information was received 26may2021.The patient received heparin during the procedure.Two units of packed red blood cells were administered due to blood loss.The other manufacturer's 5-millimeter balloon was deflated prior to attempted removal, and deflation was confirmed using fluoroscopy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during an angioplasty, a flexor ansel guiding sheath "crunched up" upon attempted removal of another manufacturer's 5-millimeter balloon through the sheath.When the stuck balloon was unable to be removed from the sheath, the user deflated the balloon and removed both the balloon and sheath together from the patient.Another sheath was used to complete the procedure.Once the device was removed, the arteriotomy site was larger than anticipated and bleeding was observed, including an expanding hematoma.A 9 french closure device was used to manage the hematoma successfully.The anatomy was not calcified.The patient received heparin during the procedure.Two units of packed red blood cells were administered due to blood loss.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, drawing, specifications, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was not returned for investigation.Photos provided by the user appear to show the shaft of the sheath wrinkled from the hub of the sheath to the distal tip.No damage was apparent on the hub.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath,¿ and, ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ based on the available information and a clinical assessment of the event, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Cook will continue monitoring of similar complaints and has 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.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11824610
• Report Number: 1820334-2021-01336
• Device Sequence Number: 11665283
• Product Code: DYB
• UDI-Device Identifier: 00827002441538
• UDI-Public: (01)00827002441538(17)230225(10)13008575
• 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
• Serviced by Third Party (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): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: G44153
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13008575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 09/01/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/10/2021; 09/15/2021
• 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: 5MM MUSTANG BALLOON; 9FR PRO GLIDE CLOSURE DEVICE; 9FR PRO GLIDE CLOSURE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention