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

Model Number	G07376
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.Pma/510(k) number = pre-amendment.Device evaluation has begun; however, a conclusion is not yet available.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 a procedure involving injection of yttrium 90 for a liver tumor/cancer, the hub of a performer introducer detached from the sheath.Nothing abnormal was observed during preparation of the device.Access was obtained in the thin patient's right femoral artery, which appeared normal, using ultrasound guidance.The access site had been used in the past for an angiogram and other unknown intervention; however, the artery was free of calcium or stenosis.The sheath was advanced over an unknown 0.035 inch j- wire guide.No resistance was reported.As the inner dilator was removed, heavy bleeding was observed around the sheath.Pressure was held; however, when pressure was released the bleeding continued.The user decided to remove the device over the wire guide using a pin and pull technique, pulling from the hub of the device, at which point the hub/valve detached.The device had been in place less than five minutes.Excessive force was not applied and resistance was not noted.The dilator was not reinserted prior to removal.The sheath was slowly removed from the patient by hand and nothing was left in the patient.Blood loss was reported to be minimal.A new sheath was used to successfully complete the 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Initial report: as reported, during a procedure involving injection of yttrium 90 for a liver tumor/cancer, the hub of a performer introducer detached from the sheath.Nothing abnormal was observed during preparation of the device.Access was obtained in the thin patient's right femoral artery, which appeared normal, using ultrasound guidance.The access site had been used in the past for an angiogram and other unknown intervention; however, the artery was free of calcium or stenosis.The sheath was advanced over an unknown 0.035 inch j- wire guide.No resistance was reported.As the inner dilator was removed, heavy bleeding was observed around the sheath.Pressure was held; however, when pressure was released the bleeding continued.The user decided to remove the device over the wire guide using a pin and pull technique, pulling from the hub of the device, at which point the hub/valve detached.The device had been in place less than five minutes.Excessive force was not applied and resistance was not noted.The dilator was not reinserted prior to removal.The sheath was slowly removed from the patient by hand and nothing was left in the patient.Blood loss was reported to be minimal.A new sheath was used to successfully complete the 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.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.One used 6.0fr rcf sheath and dilator were returned for investigation.The sheath proximal fitting and flare were separated from the tubing.There was biological matter present throughout the device, but no additional damage.The proximal fitting was disassembled, and the flare remains within the connector cap.The flare was crushed and folded over.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was 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 there were no other reported complaints for this lot number.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this complaint is manufacturing deficiency.The proximal fitting assembler was retrained in response to this incident.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: 9843758
• Report Number: 1820334-2020-00632
• Device Sequence Number: 10944467
• Product Code: DYB
• UDI-Device Identifier: 00827002073760
• UDI-Public: (01)00827002073760(17)221007(10)NS10039238
• 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
• Report Date (Section B): 08/21/2020

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: 10/07/2022
• Device Model Number: G07376
• Device Catalogue Number: RCF-6.0-35-J
• Device Lot Number: NS10039238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR