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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: cath lab.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a peripheral angiogram, a flexor high-flex ansel guiding sheath separated.Access was obtained in the common femoral artery.Another unknown manufacturer's balloon was used through the cook sheath.The unknown balloon would not deflate, so the user attempted to pop the balloon using a "few" unknown wire guides; however, this was unsuccessful.The user forcefully pulled the balloon through the sheath, at which point the balloon catheter broke and the sheath material separated and uncoiled.A snare was used to remove the separated portion of the sheath from the patient.It is believed that the procedure was completed using another sheath.There was no harm to the patient.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.

Event Description

Additional information was received 27jan2021 and was inadvertently omitted from the initial mdr.The procedure involved angioplasty and stent deployment within a calcified lesion.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional/corrected information: b5 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 Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, during a peripheral angiogram, angioplasty, and stent deployment, a flexor high-flex ansel guiding sheath separated.Access was obtained in the common femoral artery.Another unknown manufacturer's balloon was used through the cook sheath.The unknown balloon would not deflate, so the user attempted to pop the balloon using a "few" unknown wire guides; however, this was unsuccessful.The user forcefully pulled the balloon through the sheath, at which point the balloon catheter broke and the sheath material separated and uncoiled.A snare was used to remove the separated portion of the sheath from the patient.It is believed that the procedure was completed using another sheath.There was no harm to the patient.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned the complaint device to cook for investigation.Physical examination of the returned device showed: one used sheath was received.The sheath was separated into two pieces, with the separated section measuring 8.2cm.The separation points were jagged and had exposed, elongated coil.No other damage was noted.At this time, cook concluded that the device was manufactured within specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: ¿ 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.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ instructions for use: ¿1.Ensure that the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instruments to be introduced.¿ capa pr288679 was opened as a result of (b)(4).This ric was initiated following an increase in yearly complaints of patient injury or death between 2018 and 2019.These events correspond to an increase in all complaints from occurrence level of remote (2) to occasional (3).The capa team assessed the root cause to be thin wall of ptfe liner being susceptible to damage from handling and processing during profiling and coil transfer processes leading to increased susceptibility to shaft separation.This capa is currently investigating the issue.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded an unintended use error contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11245982
• MDR Text Key: 233272465
• Report Number: 1820334-2021-00194
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002562356
• UDI-Public: (01)00827002562356(17)210621(10)8968965
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: N/A
• Device Catalogue Number: KCFW-5.0-35-55-RB-HFANL1-HC
• Device Lot Number: 8968965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR