MAUDE Adverse Event Report: MEDTRONIC/ COVIDIEN/ GIVEN IMAGING INC. BRAVO PH CAPSULE; ELECTRODE, PH, STOMACH

Lot Number 50301F

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

Bravo capsule was placed with all manufacture's recommendations on holding it straight as possible.Capsule was attached to patient but was unable to be released from rest of placement device after normal deployment and the "break" emergency deployment was attempted.Placement catheter was removed with a snare placed around the tip of cath.Rat tooth grasper, alligator grasper, and 10mm snare all had to be used in attempts to remove capsule leading to additional costs and case delay.Fda safety report id# (b)(4).

• Brand Name: BRAVO PH CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC/ COVIDIEN/ GIVEN IMAGING INC.
• MDR Report Key: 10755866
• MDR Text Key: 213935004
• Report Number: MW5097550
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Lot Number: 50301F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 132