MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ION?; CORONARY DRUG-ELUTING STENT

Model Number H7493902424350

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a device seal became compromised.A product box labeled as an ion 20mmx3.5mm was received with a torn opened device pouch labeled an ion 24mmx3.50mm.Additional information has been requested and is not available.

Manufacturer Narrative

Device is combination product.(b)(4).

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: an investigation into this complaint indicates that an incorrect sized, used device was placed in a box of a different labelled size at the hospital facility.A review into the batches identified that manifold batch 16048868 was "kitted" into top assembly batch 16095708.Both top assembly batches (15212817 and 16095708) were not in the manufacturing site at the same time.The dates of manufacturing between the two devices are may 2012 and june-2013, confirming that there was no potential for a product mix up at the manufacturing site.Although both batches were present in the (b)(4) distribution centre at the same time, it was confirmed that there was no rework performed on these batches.Each container batch of different universal part numbers is clearly segregated to prevent any possibility of a product mix up.The taxus element / ion 24/3.50 device.No was received for analysis.An examination of the delivery device found clear indications of device use.There was a large build-up of contrast media present inside the inflation lumen and balloon.An examination of the balloon found that the balloon had been inflated and was not refolded.The stent was deployed from the balloon and was not received for analysis.Some kinking was noted at various locations along the hypotube.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

It was reported that a device seal became compromised.A product box labeled as an ion 20mmx3.5mm was received with a torn opened device pouch labeled an ion 24mmx3.50mm.Additional information has been requested and is not available.

• Brand Name: ION?
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3635213
• MDR Text Key: 3986159
• Report Number: 2134265-2014-01075
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

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: 10/05/2014
• Device Model Number: H7493902424350
• Device Catalogue Number: 39024-2435
• Device Lot Number: 16095708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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