MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS¿ SR PRO²; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749390140

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a hole on the catheter.During a procedure, an atlantis sr pro imaging catheter was used.However, during flushing, it was noted that the catheter could not be flushed due to a little hole at the beginning of the shaft.The procedure was completed with another atlantis sr pro imaging catheter.No patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for evaluation.A crack was observed in the m/f luer connector.Leaks were observed from the m/f luer connector during testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that there was a hole on the catheter.During a procedure, an atlantis¿ sr pro² imaging catheter was used.However, during flushing, it was noted that the catheter could not be flushed due to a little hole at the beginning of the shaft.The procedure was completed with another atlantis¿ sr pro² imaging catheter.No patient complications reported and the patient's condition was stable.

• Brand Name: ATLANTIS¿ SR PRO²
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5831781
• MDR Text Key: 50727625
• Report Number: 2134265-2016-06479
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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: 07/08/2016
• Device Model Number: H749390140
• Device Catalogue Number: 39014
• Device Lot Number: 0018179358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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
• Patient Age: 68 YR