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

Model Number	G08956
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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 valve on the performer introducer was broken.Blood was leaking.Blood loss was not quantified; however, no medical intervention was required.The physician changed to another manufacturer's sheath to complete the abdominal aneurysm repair procedure.The complaint device was introduced into the patient's common femoral artery in an ipselateral approach.A.035 glide wire was in place through the complaint device.It is not known if the patient's anatomy was tortuous or calcified.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.Additionally, it was reported an unknown number of similar issues occurred with performer introducers in the past.Please reference 1820334-2019-00082 which captures these events.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Additional information: (description of event).Blood loss was described as minimal and did not require any intervention.An unknown sheath was used to successfully complete the procedure.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 regarding the patient and/or event has been received since the previous medwatch report was sent.
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, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed one rcfw-12.0-38-30-rb was returned for investigation with the dilator fully inserted into the sheath.Biomatter was present throughout the device.The device was flushed with the dilator in place and water leaked through the silicone disc around the dilator.The dilator was removed, and the sheath was flushed again, but the water drained out the tip of the sheath as it was meant to.Hemostats were clamped onto the sheath tubing just distal to the check-flo assembly and the device was flushed again.Water beaded on the silicone disc and then a fine spray appeared when more force was applied to the syringe.The check-flo assembly was disassembled for further examination.A small tear was noted on the bottom side of the disc.The slits in the disc also appear to no longer run edge to edge on both the top and bottom sides, but there were faint lines visible on the bottom of the disc form where the disc may have mended itself.The check-flo disc is made from a two part material that is known for siloxane equilibration or ¿self healing¿.It is possible that the disc rehealed prior to the device being used, and when the dilator was inserted during prep, the disc tore causing the leakage during the procedure.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.However, during the review for the subassembly lot, a failed leakage test was noted as a nonconformances.While this nonconformance is related to the reported failure, the affect unit was scrapped and not replaced.Additionally, while reviewing the component lot from our vendor, another failed leak test was highlighted as a nonconformances.These affected devices were rejected and returned to the vendor.It should also be noted that the only other complaint for this lot number was pr250014 which was created to from this original complaint.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that this event was caused by a random component failure of the silicone disc.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: 8228929
• Report Number: 1820334-2019-00081
• Device Sequence Number: 1827502
• Product Code: DYB
• UDI-Device Identifier: 00827002089563
• UDI-Public: (01)00827002089563(17)211019(10)9184001
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 03/13/2019

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: 10/19/2021
• Device Model Number: G08956
• Device Catalogue Number: RCFW-12.0-38-30-RB
• Device Lot Number: 9184001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 03/13/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/18/2019; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PREVIOUSLY STATED