MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51006015L

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was confirmed that a sterilized pouch of a saber rx 6 mm 15 cm 155 was deformed and had hole(s).The damaged part seemed to have been blistered.The procedure finished successfully.There was no reported patient injury.The product was not clinically used and only the sterilized pouch will be returned for analysis.This was an endovascular treatment case.The patient¿s information, target lesion, vessel level of tortuousness, calcification and the rate of stenosis was unknown.Additional information has been requested.

Manufacturer Narrative

The sections were updated accordingly: a review of the manufacturing documentation associated with this lot 17599235 presented no issues during the manufacturing process that can be related to the reported complaint.

Event Description

It was confirmed that a sterilized pouch of a saber rx 6mm 15cm 155 was deformed and had hole(s).The damaged part seemed to have been blistered.The procedure finished successfully.There was no reported patient injury.The product was not clinically used and only the sterilized pouch will be returned for analysis.This was an endovascular treatment case.The patient¿s information, target lesion, vessel level of tortuousness, calcification and the rate of stenosis was unknown.The integrity of the sterile pouch was not compromised, there was a pinhole on the pouch that was deformed by fever.The product had not been purposely opened in anticipation of use and when not used was re-shelved, the package had no abnormality.The damage was noted before use at the hospital.The product was sent to the hospital the day before the procedure and stored in a large corrugated board.The actual product was not damaged, it was visually confirmed.The product was used in the procedure.

Manufacturer Narrative

The following sections have been updated accordingly.A sterilized pouch of a saber rx 6mm 15cm 155cm balloon catheter (bc) was deformed and had hole(s).The damaged part seemed to have been blistered.The procedure finished successfully.There was no reported patient injury.This was an endovascular treatment case.The patient¿s information, target lesion, vessel level of tortuousness, calcification and the rate of stenosis was unknown.The integrity of the sterile pouch was not compromised, there was a pinhole on the pouch that was deformed by fever.The product had not been purposely opened in anticipation of use and when not used was re-shelved, the package had no abnormality.The damage was noted before use at the hospital.The product was sent to the hospital the day before the procedure and stored in a large corrugated board.The actual product was not damaged, it was visually confirmed.The product was used in the procedure.The product was returned for analysis.One non-sterile inner pouch of saber rx 6mm x 15cm155 was returned.Per visual analysis it was noted that the inner package had a rupture with scratched and ripped characteristics.The pouch had been opened; however the complaint description summary states that ¿the product was used in the procedure¿ and the saber product was not returned for analysis.No other anomalies were noted.Per microscopic analysis the scratched and ripped characteristics were confirmed.A product history record (phr) review of lot 17599235 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/ pouch/box - compromised sterility - sterile barrier breached¿ and ¿packaging/ pouch/box ¿ frayed/split/torn - inner package¿ were confirmed through analysis of the returned product.The exact cause of the event could not be determined during analysis.Based on the information available for review, shipping or handling factors may have contributed to the event as evidenced by scratches and rips noted on the outer surface during analysis.According to the warnings in the safety information in the instructions for use ¿store in a cool, dark, dry place.Use the catheter prior to the ¿use by¿ date specified on the package.Do not use if inner package is opened or damaged.¿ neither the phr 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: SABER RX6MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7029656
• MDR Text Key: 93004643
• Report Number: 9616099-2017-01577
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 51006015L
• Device Lot Number: 17599235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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
• Patient Outcome(s): Life Threatening