MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number G07919

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) number = pre-amendment.Device evaluation is in progress.Conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was initially reported that the performer introducer was found damaged in the package.There was no patient contact.Upon return of the device to the manufacturer, a split was observed to the tip, or distal end, of the complaint device.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the distal end of the dilator was partially compressed, with a 1 mm split present as well.The dilator accepted a 0.035¿ wire guide with a smooth transition.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7468680
• MDR Text Key: 106756980
• Report Number: 1820334-2018-00735
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002079199
• UDI-Public: (01)00827002079199(17)201218(10)8419095
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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
• Device Operator: Health Professional
• Device Model Number: G07919
• Device Catalogue Number: RCFW-6.0-35-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• 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