MAUDE Adverse Event Report: COOK INC POLYETHYLENE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The international customer reported that, prior to use of the polyethylene angiographic catheter, product damage was discovered in the form of a slit on the drainage catheter.Another product from a different lot was ultimately employed instead.The customer confirmed that the product issue was identified prior to patient contact; accordingly, no patient adverse events occurred.The product was received for evaluation, and as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation summary: a review of complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control documents, manufacturing instructions, specifications, and visual inspection was conducted on the returned device during the investigation.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the catheter pigtail was visually inspected by quality control for this type of defect, and no notable gaps in production or processing controls were noted.The risk specification for this product considers the design element ¿catheter¿ potential failure modes ¿unable to track catheter into target site¿, ¿separation of tip from shaft and suture (if applicable)", and "unable to place catheter over wire guide (if applicable)".Because these may be related but are not specific to this failure mode, a risk analysis was written in response.It identifies several risk mitigating efforts to prevent this failure and concludes that no additional risk mitigation activity is required.The device history record for lot number was reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.The product was returned, and it was found that the outer circumference of the pigtail curve had a split measuring 15 mm.There was no evidence to suggest that the device was not manufactured to specification.It is possible, based on the provided information, that the root cause of this event related to shipping, storage, or handling or a failure to heed the ifu instruction to use extreme care during manipulation; however, we do not have enough evidence to identify a definitive root cause at this time.The complaint will be confirmed based on an evaluation of the returned product.The risk analysis for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: POLYETHYLENE ANGIOGRAPHIC 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 ; 8123392235
• MDR Report Key: 6902260
• MDR Text Key: 88254654
• Report Number: 1820334-2017-03273
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002081055
• UDI-Public: (01)00827002081055(17)191201(10)7451877
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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