MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS

Catalog Number PC0930XCE

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product was returned for analysis, however the engineering evaluation has not yet been completed.A dhr review was conducted and it was determined these lots met all requirements per the manufacturing plan.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported that there was breakage at the tip of the delivery shaft of a 6f 9.0mmx30mm precise pro stent delivery system during flushing prior to use.It appeared to be cracked.They stopped using this device and changed to a same-like one to complete the procedure.There was no report of patient injury.The device was stored, handled, and prepped according to the ifu.There weren't any anomalies or other damages noted to the device or packaging prior to use.The device had not yet been advanced to the target lesion during use.The device will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: the tip of a 9 x 30mm precise pro rx stent delivery system (sds) was noted to be cracked while being flushed prior to use.The procedure was successfully completed with a similar device.The site reported that the device had been stored, handled and prepped according to the instructions for use (ifu).There were no anomalies or damage noted to the device or its¿ packaging prior to use.The site reported that the tip of the sds was noted to be cracked while they were flushing it.The device was not used in the patient and the procedure was successfully completed with a similar device with no reported patient injury.One non-sterile precise pro rx ous carotid system, 6f, 9mm x 30mm, 135 cm catheter was received for analysis inside a plastic bag with the stent in a separate small plastic bag.A breakage at the tip of the delivery shaft was noted.No other anomalies were observed.The tip of the unit was inspected under the vision system and a scratch/crack was observed on the distal tip.Sem analysis revealed that the external surface had evidence of scratches/slits on the catheter tip.This damage was consistent with the action of a sharp object applied from a distal to a proximal direction on the catheter¿s distal tip.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The manufacturing process was reviewed and there were no tools, equipment or product handling that could have caused this type of damage.The reported ¿catheter tip - cracked¿ event was confirmed based on the visual analysis of the device.However, the exact cause of this damage could not be conclusively determined during the analysis; but does not appear to be related to the manufacturing process.According to the product ifu, users are instructed to carefully inspect the packaging and device for any damage and to not use the device if they suspect that the sterility and/or device performance has been compromised.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However since the damage does not appear to have occurred during the manufacturing process, handling of the device at the site may have contributed to it.Neither the device history record review nor the product analysis suggests that the reported event could be related to the manufacturing process.Therefore, no corrective actions will be taken.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5039271
• MDR Text Key: 24784930
• Report Number: 9616099-2015-00399
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: PC0930XCE
• Device Lot Number: 15945754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1