MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number 364503

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Event Description

During unpacking, it was detected that the sterile pouch had two holes/tears.Device was not used.

Manufacturer Narrative

3/14/19 - added model number to this report.The returned device and the card box were subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the cardboard box has been opened on the opposite side of the quality seal.At the flap of the cardboard box several scratches are visible.The sterile pouch has two tears just above and at the product label.Next to the tears scratches were observed.Furthermore, deep scratches were found in the storage ring which is located inside the sterile pouch.These findings indicate that both the sterile pouch and the storage ring were damaged during opening of the cardboard box with a hard sharp-edged object.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The most probable root cause for the complaint event is therefore related to external factors during the incorrect opening of the card box and sterile pouch.

• Brand Name: ORSIRO 3.5/22
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 8416627
• MDR Text Key: 138665874
• Report Number: 1028232-2019-01107
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: 364503
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05184350
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1