MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558480

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

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon device was unpacked on (b)(6) 2017.According to the complainant, while unpacking after the package was received, they noticed that there was a hole on the sterile packaging near the device label.There was no visible damage noted on the outer box.Reportedly, this device was not being used for a patient or procedure.F.

Manufacturer Narrative

A visual examination of the complaint device found that the package has a hole near the information label of the device.The package bonds were also inspected around the pouch and found to be continuous and intact.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon device was unpacked on (b)(6) 2017.According to the complainant, while unpacking after the package was received, they noticed that there was a hole on the sterile packaging near the device label.There was no visible damage noted on the outer box.Reportedly, this device was not being used for a patient or procedure.

• Brand Name: CRE¿ WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7076654
• MDR Text Key: 94201728
• Report Number: 3005099803-2017-03500
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 21260166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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