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

Model Number G47701

Device Problems Detachment of Device or Device Component (2907); Sharp Edges (4013)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, the valve came off flexor high-flex ansel guiding sheath.There was no report of any patient adverse effect.Information regarding event details, patient demographics, and outcome were requested but is unavailable at this time.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

During preliminary investigation of the complaint device on 22 mar 2019, it was noted the sheath was kinked with sharp edges.This follow up report is submitted for this additional failure mode.

Manufacturer Narrative

Reviews of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and a functional test & 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 and its corresponding dilator were returned to cook for investigation.A kink was noted 3.2cm from the proximal hub of the sheath and the endhole was noted to be out of round.The kink was found to be sharp.The hub was separated from the dilator.A.162 pin gauge passed through the device, while the.163 pin gauge did not.The flare of the dilator was found to be insufficient.Consistent with these findings, investigation was able to recreate the reported failure mode.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 be noted that the only other complaint associated with this lot number was created to capture an additional failure (kink with sharp edges) from this original case.Furthermore, reviews of the manufacturer¿s instructions, drawings, quality control procedures, and overall design history file were conducted, and no gaps were discovered.Through these reviews, cook has confirmed that sufficient inspection activities are in place to prevent this reported failure prior to distribution.Moreover, a review of the product labeling and ifu concluded that no specific information is provided to the user related to this specific failure mode.Based on the information provided and the examination of the returned product, investigation has concluded that this event was likely caused by the manufacturing and quality control process.During the functional testing of the device, the flare of the dilator was confirmed inadequate.Measures are being conducted to address this failure mode.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Pma/510(k) number = k142829.Investigation ¿ evaluation.It was reported that the hub of the dilator disconnected from the dilator shaft during an unknown procedure on (b)(6) 2019.The patient reportedly experienced no adverse effects as a result of this incident and no additional harm was reported.The device was returned to aid in the investigation, however, additional details of the event were not provided despite attempts made by cook to the customer.Reviews of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The complainant returned the flexor high-flex ansel guiding sheath and its corresponding dilator to cook for investigation.Physical examination of the returned device noted a sharp kink 3.2 cm from the proximal hub of the sheath and the endhole of the sheath was noted to be out of round.The device was returned with the dilator material separated from the hub.The reported failure was evident to investigators.The complaint file, complaint history, device failure analysis, device history record, validations, and manufacturing documents were reviewed and provided evidence that the device was manufactured to specification.According to the device history record, there were no relevant manufacturing nonconformances associated with the complaint product lot.A search for similar complaints on the complaint product lot revealed this to be the only complaint related to the failure of dilator hub separation.Product labeling was also reviewed during the investigation.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package.The complaint investigation did not establish a definitive cause for this event.However, a previously opened capa investigated this failure of dilator hub separation.The capa was completed and found that the root cause of the failure is inadequate process controls leading to undersized flares.This can result in inadequate tensile strength at the hub joint.In response, a 100% inspection utilizing a flare gauge was implemented as part of the manufacturing process.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Upon review of risk documentation, no additional risk mitigation activities are necessary at this time.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No new patient or event information received since the last report was submitted.

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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: 8405505
• MDR Text Key: 138429178
• Report Number: 1820334-2019-00434
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)211128(10)9338656
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: G47701
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Device Lot Number: 9338656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1