MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO; BRAVO PH CAPSULE

Model Number FGS-0313

Device Problems Failure To Adhere Or Bond (1031); Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported on a bravo ph capsule that failed to attach.The patient was not injured following the procedure.

Manufacturer Narrative

(b)(4).There was no required intervention to prevent permanent impairment/damage in this case.Evaluation summary: one delivery system was returned to medtronic for evaluation.The capsule was not returned for evaluation.The delivery system was investigated visually for external damage.There were no signs of blood or tissue on the device.The delivery system was not bent; the plunger was not broken, but the plunger was not pushed to the end.The emergency release on the delivery system was not implemented.The capsule electrodes were visually acceptable.The wire that holds the capsule was completely off and the foam gasket was in good condition.The delivery system did not have any visible damage.As the product was received, the device functioned per specification.The plunger not pushed to the end is indicative of mishandling.

• Brand Name: BRAVO
• Type of Device: BRAVO PH CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building; new industrial park, p.o box 258; yokneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD.; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4801909
• MDR Text Key: 20062648
• Report Number: 9710107-2015-00141
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2015
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 27259Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention