MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Catalog Number 67005400

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the 100 cm.6 fr.Xb 3.5 guiding catheter was noted to be damaged inside the original packaging.There was no reported patient injury.Multiple attempts to obtain additional information were unsuccessful.No additional information is available.Addendum: based on the results of the product evaluation the failure mode of packaging/pouch/box-compromised sterility was added.

Manufacturer Narrative

As reported, the 100 cm.6 fr.Xb 3.5 guiding catheter was noted to be damaged inside the original packaging.There was no reported patient injury.Multiple attempts to obtain additional information were unsuccessful.No additional information is available.A non-sterile of 6f.070 xb 3.5 100cm unit was received inside of its original pouch, the pouch was received four-ply folded, however, the seal area of pouch was observed as damaged (sterility compromised).The pouch mylar and tyvek, as well as the mounting card, was observed dented.In the seal area, a severe ripped/torn condition was observed.Also, the hook presented the same dented characteristics.The unit was removed from the pouch, and per visual analysis, four kinked/bent conditions were noted on catheter body at 21.5 cm, 42cm, 59.5 cm and 79.5 cm from distal end.It was observed that theses kinked/bent conditions corresponds to the points where the catheter was folded.No other damages/anomalies were noted.Meeting was held with the pet in order to review the received complaint unit, the unit was evaluated and was observed.No missed crows, neither hub misalignment (described as the hub not aligned with the cut out in the mounting card that could lead the catheter incorrectly positioned over the mounting card) was observed inside its primary packaging.Therefore, based on the performed analysis, it was concluded that there was no evidence that these damages could be related to the manufacturing process.The catheter¿s body outer diameter and inner diameter was measured near the kinked conditions and results were found within specification.A device history record (dhr) review of lot 17516417 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Additionally, controls are in place as visual inspection 100% for catheter sub assembly and visual inspection 100% for catheter final assembly as part of the manufacturing process in order to detect defects as the reported failure before of the product leaves the manufacturing site.The reported ¿catheter (body/shaft) - damaged - prior to use¿ was confirmed due to the kinked/bent conditions found on catheter body.Additionally, the seal area of the pouch was found ripped and torn, compromising sterility of the device, and the hook was dented.The exact cause of the damages noted to the returned device and the packaging could not be conclusively determined during analysis.However, based on the limited information available for review and due to the condition in which the device was returned for analysis (folded in four places), it is highly likely that the kinked conditions and torn packaging may have been caused by handling factors of the device, especially during the six months it was stored before return for analysis.As cautioned in the instructions for use, which is not intended as a mitigation, ¿do not use open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 XB 3.5 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6904183
• MDR Text Key: 87774591
• Report Number: 9616099-2017-01474
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 67005400
• Device Lot Number: 17516417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/07/2017
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2016
• 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