MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that during the procedure, foreign material was found.The intellamap orion¿ was used with a zurpaz¿ 8.5f steerable sheath.The orion catheter was removed multiple times to be flushed in a saline bowl throughout the procedure.On roughly the third time, the orion was removed and flushed the physician noted two black substances floating in the bowl.After careful removal of the black substance, he removed the sheath off the orion catheter only to notice another black particle at the insertion site of the sheath.It is unclear whether it was the zurpaz sheath or the orion catheter that was the culprit.No patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer - unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was visually inspected and no foreign matter was found along the tip and array section.A non-biological black foreign matter was found.Also, the zurpaz sheath dilator was examined, and it was identified that some of the ink marks were missing.It was concluded that the foreign matter was consistent with the black ink patches of the sheath dilator used during the procedure.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause classification of this event is that another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that during the procedure, foreign material was found.The intellamap orion¿ was used with a zurpaz¿ 8.5f steerable sheath.The orion catheter was removed multiple times to be flushed in a saline bowl throughout the procedure.On roughly the third time the orion was removed and flushed the physician noted two black substances floating in the bowl.After careful removal of the black substance, he removed the sheath off the orion catheter only to notice another black particle at the insertion site of the sheath.It is unclear whether it was the zurpaz sheath or the orion catheter that was the culprit.No patient complications were reported.

• Brand Name: INTELLAMAP ORION?
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4608745
• MDR Text Key: 21337231
• Report Number: 2134265-2015-01252
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17545359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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
• Treatment: STEERABLE SHEATH: ZURPAZ¿ 8.5F