MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JINRO? PIGTAIL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number M0064202040

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jinro pigtail procedural kit was opened for use in a gastrostomy procedure.According to the complainant, during unpacking, they noted that there was a hole on the sterilized bag and they elected not to use this device.The procedure was completed with another jinro pigtail procedural kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Visual examination of the returned jinro pigtail procedural set revealed that the pouch was broken at the inferior left corner.However, all the seals were inspected and no anomalies or damages noted.Therefore, the condition of the returned device confirms the reported event of hole in the sterilized package.Given the event description and condition of the returned device, the circumstances under which the package was damaged cannot be determined based on the information available.Therefore, the most probable root cause is ¿undeterminable.¿ a review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a jinro pigtail procedural kit was opened for use in a gastrostomy procedure.According to the complainant, during unpacking, they noted that there was a hole on the sterilized bag and they elected not to use this device.The procedure was completed with another jinro pigtail procedural kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: JINRO? PIGTAIL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4687872
• MDR Text Key: 5871575
• Report Number: 3005099803-2015-01033
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2017
• Device Model Number: M0064202040
• Device Catalogue Number: 420-204
• Device Lot Number: 17457892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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