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

Model Number	G29982
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address- street: (b)(6); phone: (b)(6); postal: (b)(6).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 a procedure involving a stenosed superficial femoral artery, a flexor ansel guiding sheath stretched.After arterial access was obtained, the sheath was reportedly difficult to advance over an unknown hydrophilically-coated wire guide due to "fibrosis in the scarpa".An unknown catheter and balloon were placed through the sheath.After the balloon was deflated, it was reportedly difficult to remove from the sheath, which subsequently elongated five centimeters from the tip.The entire system was removed from the patient over the wire guide.Another sheath was then used to successfully complete the percutaneous transluminal angioplasty and stent placement procedure.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5 h3: device evaluated by mfg = other (81) - 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.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
Additional information was received.Contralateral access was obtained in the femoral artery to target the superficial femoral artery.Unknown 0.035-inch wires, a 5-french catheter, and a balloon were used through the sheath, which was in place for forty minutes.Scarring was reported.A 6-french sheath was used to complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: h6 (annex a).Summary of event: as reported, during a procedure involving a stenosed superficial femoral artery, a flexor ansel guiding sheath stretched.Contralateral access was obtained in the femoral artery to target the superficial femoral artery.Scarring was reported.After arterial access was obtained, the sheath was reportedly difficult to advance over an unknown hydrophilically-coated wire guide due to "fibrosis in the scarpa".An unknown 5 french catheter.0.035-inch wire, and balloon were placed through the sheath, which was in place for forty minutes.After the balloon was deflated, it was reportedly difficult to remove from the sheath, which subsequently elongated five centimeters from the tip.The entire system was removed from the patient over the wire guide.A 6 french sheath was then used to successfully complete the percutaneous transluminal angioplasty and stent placement procedure.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures was conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation with the dilator inserted into the sheath.The dilator did not exit the distal tip of the sheath.Sheath elongation was noted at approximately 35.3cm from the white cap and measured 6.2cm in length.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu warns ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any resistance identified or consider alternate treatment strategy.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that the device was manufactured to specification.There is no evidence of non-conforming product in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this incident, as the tissue was noted to be scarred.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or event has been received since the last report was submitted.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13156429
• Report Number: 1820334-2022-00015
• Device Sequence Number: 3979234
• Product Code: DYB
• UDI-Device Identifier: 00827002299825
• UDI-Public: (01)00827002299825(17)241020(10)14295005
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2022

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: 10/20/2024
• Device Model Number: G29982
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 14295005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 02/08/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/25/2022; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown