MAUDE Adverse Event Report: COOK INC SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

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	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the catheter was removed from packaging and advanced over the wire during a coronary artery fistula closure procedure.It was then noted there was no tip on the catheter and the catheter tip was still in the packet.The catheter was removed.Reportedly there was no patient impact.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.
Additional Manufacturer Narrative
A review of the device history record, complaint history, documentation, quality control and visual inspection of the returned device was conducted during the investigation.A document based investigation evaluation was also 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 slip-cath beacon tip hydrophilic angiographic catheter was returned for evaluation.Visual inspection of the returned device revealed kinks at the proximal end of the catheter tip with the hub intact.The distal tip of the catheter was noted to be frayed and separated into two pieces.The lumen was checked with a wire guide and was noted to be obstructed.Based on the available information factors related to shipping, handling, and/or storage of the device may have contributed to the reported failure.The most likely root cause may be related to human factors issues.Measures have been previously conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6241290
• Report Number: 1820334-2017-00042
• Device Sequence Number: 10919311
• Product Code: DQO
• UDI-Device Identifier: 00827002120082
• UDI-Public: (01)00827002120082(17)170101(10)4702873
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K122937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

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: SCBR5.0-38-100-P-NS-C2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2610-/2623-2016
• Patient Sequence Number: 1
• Patient Weight: 150