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

Model Number	G48192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported, a (b)(6) old female patient underwent a procedure for a celiac and "sma" stenosis.Access was reportedly via the left radial artery.There was no calcification, angulation, or tortuosity.A flexor ansel guiding sheath, was used and was in place for approximately one hour and thirty-four minutes.A closure device was not used.The patient developed a sterile abscess at the radial artery access site.No medical intervention was provided.The patient is improving after the procedure and did not require any additional procedures.
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, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide a photo of the product label and two low quality photos of the patient¿s arm.However, it was difficult to see the access site.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 shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿adverse events that may be associated with the use of an introducer set include, but are not limited to: local inflammation, local pain, access site infection¿ based on the information provided and no product returned, investigation has concluded that per the ifu this outcome falls under the known and inherent risks of using this device.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.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.
Event or Problem Description
No new patient or event information received since the last report was submitted.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.Corrected information: g5.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 ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8391235
• Report Number: 1820334-2019-00543
• Device Sequence Number: 16525155
• Product Code: DYB
• UDI-Device Identifier: 00827002481923
• UDI-Public: (01)00827002481923(17)211121(10)9328851
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: G48192
• Device Catalogue Number: KCFW-5.0-18/38-110-RB-ANL0-HC
• Device Lot Number: 9328851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 03/17/2020
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/24/2019; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR