MAUDE Adverse Event Report: COOK INC BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 10/27/2014

Event Type  Injury  

Event Description

The tip of the catheters became attached inside the patient.The detached portion was able to be removed successfully via unknown method of retrieval.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

One device was returned in an opened and used condition.Six devices were returned unopened and unused.During the course of investigation, a visual inspection of the returned products was conducted along with reviews of the complaint history, ifu and qc specifications.A visual inspection noted that the used device's distal tip was separated into three parts and the tip of the catheter was brittle.The six unused devices did not note any imperfections; however, when removed from the package for investigation the catheter tips were very brittle and when bent the distal tips split.Per quality control specification, the surface of catheter is verified to be free of damage and excess bumps or roughness and the wire braided catheter surface free of exposed wires.The distal tip/end hole is also verified to be rounded smooth, not thin, slanted, or out of round with no splits, nicks, damage, excess material or debris present.This product is shipped with an ifu, which states under precautions "due to thin wall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible" / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." based on the information provided and the investigation results, we are unable to determine with certainty the root cause for the difficulty experienced.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), further risk reduction is recommended.

Manufacturer Narrative

(b)(4).Maude report # mw5039366.Event evaluation: one device was returned in an opened and used condition.Six devices were returned unopened and unused.During the course of investigation, a visual inspection of the returned products was conducted along with reviews of the complaint history, ifu and qc specifications.A visual inspection noted that the used device's distal tip was separated into three parts and the tip of the catheter was brittle.The six unused devices did not note any imperfections; however, when removed from the package for investigation the catheter tips were very brittle and when bent the distal tips split.Per quality control specification, the surface of catheter is verified to be free of damage and excess bumps or roughness and the wire braided catheter surface free of exposed wires.Ithe distal tip/endhole is also verified to be rounded smooth, not thin, slanted, or out of round with no splits, nicks, damage, excess material or debris present.This product is shipped with an ifu; which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible." / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." based on the information provided and the investigation results, we are unable to determine with certainty the root cause for the experienced difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) further risk reduction is recommended.(b)(4).

Event Description

The tip of the catheters became detached inside the patient.The detached portion was able to be removed successfully via unknown method of retrieval.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.As reported on maude event report received 20apr2015 - while performing angiogram with bilateral runoff and stent to the right femora artery, the radiologist noted that the tip of the 4fr omniflush cook catheter was "split" and appeared to separate.A snare was used to successfully retrieve the fragment.Pt was not seriously injured and no intervention required other than to snare the fragment.Guidewire exchanged.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4258807
• MDR Text Key: 5103458
• Report Number: 1820334-2014-00605
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2014,10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: N/A
• Device Catalogue Number: HNR4.0-35-65-P-8S-VCF
• Device Lot Number: 4527407
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2014
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2015; 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 82