MAUDE Adverse Event Report: COOK INC FLEXOR RADIAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a radial coronary angiogram procedure on a female patient with preexisting various cardiac issues, it was noted that during the procedure, blood was leaking through the one way valve.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Mfr site, device evaluated by mfr? - corrected information.Investigation - evaluation.A review of the complaint history, device history record, documentation, quality control and visual inspection and functional test of the returned device was conducted during the investigation.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.One used flexor radial access set was returned for investigation.The product was liquid leak tested by occluding the distal end of the sheath using hemostats and syringing water through the connecting tube.The blue valve leaked through the center of the disc.With little pressure, the water tended to squirt from the valve in a small stream.As pressure was increased, the valve appeared to maintain haemostasis.Based on the information provided, examination of the returned device and the results of our investigation, the root cause was determined to be component related.The blue valve used in the production of this lot has been made obsolete and is no longer being used to manufacture these introducers.This device lot was manufactured prior to the effective date of the change.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a radial coronary angiogram procedure on a female patient with preexisting various cardiac issues it was noted that blood was leaking through the one way valve.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR RADIAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5503550
• Report Number: 1820334-2016-00148
• Device Sequence Number: 820606
• Product Code: DYB
• UDI-Device Identifier: 00827002356030
• UDI-Public: (01)00827002356030(17)180917(10)6117269
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K132592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2016

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 Model Number: N/A
• Device Catalogue Number: KCFN-6.0-18-13-RA-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2016
• Supplement Report FDA Received Date: 01/12/2017
• 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