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

Model Number G56236

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: tech.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 an angiogram via access in the left groin, the tip of a flexor high-flex ansel guiding sheath separated upon removal of the device.Unknown wire guides, a balloon, and a stent were also used during the procedure.The complaint device had been in place for fort-five to sixty minutes.Resistance was not reported.An unknown wire was in the lumen of the sheath at the time of device removal and separation; however, the dilator was not reinserted prior to removal of the sheath.All pieces of the sheath were pulled out and the patient was stable.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 Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, during an angiogram via access in the left groin, the tip of a flexor high-flex ansel guiding sheath separated upon removal of the device.Unknown wire guides, a balloon, and a stent were also used during the procedure.The complaint device had been in place for fort-five to sixty minutes.Resistance was not reported.An unknown wire was in the lumen of the sheath at the time of device removal and separation; however, the dilator was not reinserted prior to removal of the sheath.All pieces of the sheath were pulled out and the patient was stable.Investigation ¿ evaluation: a visual inspection and dimensional verification 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, and manufacturing instructions.The complainant returned the complaint device to cook for investigation.Physical examination of the returned device showed: one used sheath was received.An 8.1 cm section of the distal end was separated, separating at the proximal bond.The separated segment was attached by a piece of elongated coil.No additional damage was noted.As a far was previously opened resulting in a recall, and a capa and scar are currently opened to address this issue, the device will be confirmed as manufactured out of 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: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal form package, inspect the product to ensure no damage has occurred.¿ a capa and scar are currently open and ongoing in relation to this failure mode.Cook concluded that a manufacturing issue contributed to this event.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: 11331779
• MDR Text Key: 266677548
• Report Number: 1820334-2021-00338
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002562363
• UDI-Public: (01)00827002562363(17)230805(10)13348998
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: G56236
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Device Lot Number: 13348998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1