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

Model Number	G49570
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.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 or Problem Description
As reported, during an unknown procedure involving a patient with a history of coronary artery disease, peripheral artery disease, and diabetes mellitus, a flexor introducer sheath dilator separated as the physician was removing the dilator from the sheath over a 0.035 inch hi-wire.The patient's anatomy was reportedly calcified within the common femoral artery and at the bifurcation.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unavailable.B5: additional information.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 09dec2019.As reported, the procedure performed was a contralateral intervention of the superficial femoral artery via common femoral access.The separated dilator segment was then removed from the sheath using a hi-wire.No devices other than the hi-wire were utilized through the sheath.The procedure was completed with "no issues" with a replacement sheath.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: g5.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
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, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure involving a patient with a history of coronary artery disease, peripheral artery disease, and diabetes mellitus, a flexor introducer sheath dilator separated as the physician was removing the dilator from the sheath over a 0.035 inch hi-wire.The patient's anatomy was reportedly calcified within the common femoral artery and at the bifurcation.Additional information was received 09dec2019.As reported, the procedure performed was a contralateral intervention of the superficial femoral artery via common femoral access.The separated dilator segment was then removed from the sheath using a hi-wire.No devices other than the hi-wire were utilized through the sheath.The procedure was completed with "no issues" with a replacement sheath.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.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, dimensional verifications, and a visual inspection of the complaint device was conducted during the investigation.The complaint device was returned for investigation.The sheath and dilator were returned with bio-matter present and the dilator inserted.The dilator hub was detached from the shaft cleanly with no material in the hub.It was noted that the sheath shaft is slightly elongated.The dilator was removed from sheath for the examination.The outer diameter of the dilator measured within specification.The insert molded hub of the dilator experienced pullout of the dilator shaft during manufacture causing a decrease in surface area.No other damage was noted.A supplier investigation was conducted due to the inject molding issue identified in the device failure analysis.The investigation concluded that the failure was caused by an error in the insert molding process.Because this is a known risk associated with the manufacturing process and no devices from the dilator lot failed the minimum load requirement, no action was taken to address the issue.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.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.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 additional nonconforming product exists in house or in the field.The product ifu states: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the results of the investigation, cook has concluded that compression of the sheath, due to the calcification in the vessel, as well as the manufacturing error found in the hub caused an increase in the force required to remove the dilator and the hub separated as a result.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 and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9437831
• Report Number: 1820334-2019-03044
• Device Sequence Number: 2934566
• Product Code: DYB
• UDI-Device Identifier: 00827002495708
• UDI-Public: (01)00827002495708(17)220926(10)10040380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2020

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: 09/26/2022
• Device Model Number: G49570
• Device Catalogue Number: KCFW-5.0-38-45-RB
• Device Lot Number: 10040380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 04/28/2020; 08/14/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/16/2019; 04/29/2020; 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR