MAUDE Adverse Event Report: COOK INC FLEXOR BALKIN 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Once the introducer was in place during the procedure and being used for some time, the side arm snapped off.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).Initial was filed within the 30 day time frame regardless of corrected date.Investigation - evaluation: a review of the complaint history, device history record, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the sheath and dilator were returned in a used condition.Visual examination of the separated side arm showed very little or no glue residue.This would indicate an insufficient amount of glue may have been used in the manufacturing process.The device is shipped with an instruction for use (ifu) which states the intended use, contraindications, warning, precautions and instructions for use.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A 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.Based on the information provided, device examination and the results of our investigation, the root cause of this event is related to an insufficient amount of glue used in the manufacturing process.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Once the introducer was in place during the procedure and being used for some time, the side arm snapped off.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 BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5466231
• Report Number: 1820334-2016-00119
• Device Sequence Number: 18896622
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)181028(10)6327644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2016

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: KCFW-8.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2016
• Supplement Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1