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

Model Number	G11672
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
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, the performer introducer was removed from the packaging in it's usual state with the dilator backloaded.During preparation of the device, the dilator was removed from the tip of the performer introducer and was inserted through the valve with difficulty but was fully inserted.Upon insertion into the patient's left common iliac artery, dilator removal was attempted but proved difficult.The dilator was eventually removed using hemostats and a vigorous pull which broke the hub end of the dilator.Another device was used to successfully complete the fenestrated endovascular aneurysm repair procedure.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 or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: previously unreported additional information was received from the customer.The customer confirmed that the device was used over a.035 size wire guide, and that the patient's anatomy was slightly calcified.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
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.A review of the complaint history, device history record, manufactures instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one rcfw-18.0p-38-30-rb was returned for investigation.The dilator was returned partially inserted into the sheath.There was no hub on the dilator and it was not returned with the device.The dilator was removed from the sheath with excessive force after the device was soaked with water.There appeared to be hemostat marks on the proximal end of the dilator.Biomatter was present in the valve of the device.The proximal fittings were disassembled for further examination, and in related pr252319, it was determined that there was glue partially occluding the lumen of the check-flo body.Additionally, a document based investigation evaluation was performed.There is 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 also be noted the only other complaints for this lot number were pr252319 & pr228045 which were created from this complaint for trending purposes.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could be traced to manufacturing.There was evidence of excess glue applied when the sheath proximal fittings were attached, making this device out of specification.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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7993713
• Report Number: 1820334-2018-03109
• Device Sequence Number: 19267332
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)200831(10)8145376
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/22/2019

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: 08/31/2020
• Device Model Number: G11672
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 8145376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 02/21/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/12/2018; 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR