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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note this report is past the 30 day timeframe for reporting due to internal miscommunication.(b)(4).This event is still under investigation at this time.
Event or Problem Description
During an unknown procedure on the (b)(6) year old male patient, resistance was experienced with the introducer.During advancement of the introducer, the valve released (separated) from the introducer (separated from hub).No adverse consequence to the patient reported.
Additional Manufacturer Narrative
Investigation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of a photographic image of the device was conducted during the investigation.The complaint device was not returned, therefore no physical examinations could be performed; however, a document-based investigation was performed, including visual inspection of a photographic image of the device.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.It is possible that the sheath might have got caught onto the tortuous anatomy of the patient and the force excreted on it while removal could have caused the hub separation based on the available information, no device being returned, it is possible that the patient¿s clinical condition (tortuous anatomy), and/or the healthcare professional¿s technique/procedure (ifu clearly instructs not to insert/withdraw the introducer if resistance is felt) may have contributed to this event.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
Event or Problem Description
A flexor raabe guiding sheath was placed in the internal iliac artery during an unspecified procedure on a (b)(6) year old male.It was reported that the raabe sheath was placed over a 12fr sheath and a amplatz wire guide in tortuous anatomy.During removal of the sheath, resistance was felt and the valve separated from the hub of the introducer.The dilator was fully inserted into the sheath.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.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6432276
• Report Number: 1820334-2017-00604
• Device Sequence Number: 512499
• Product Code: DYB
• UDI-Device Identifier: 00827002116375
• UDI-Public: (01)00827002116375(17)180707(10)6014201
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2017

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: KCFW-8.0-38-70-RB-RAABE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided; 09/11/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 05/08/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR