BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
|
Back to Search Results |
|
Catalog Number D128211 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/15/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional clarification is being requested on the facility.The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30028571l number, and no internal action related to the reported complaint condition were identified.(b)(4).
|
|
Event Description
|
It was reported that a patient underwent an atrial tachycardia procedure with a pentaray nav high-density mapping eco catheter, and the introducer was stuck and slipped within the sheath.The physician had difficulty passing the pentaray nav high-density mapping eco catheter in the 8f introducer.When the catheter was removed, the protector became stuck in the introducer.The physician had to cut off the protection to re-engage the catheter and again tried to pass it over to the mobicath, which was also unsuccessful.The pentaray nav high-density mapping eco catheter still did not progress.When the pentaray protector was replaced by the smarttouch protector, the catheter progressed normally.The procedure was completed successfully.There was no patient consequence.Additional information was received on the event clarifying that protector was found dislodged inside the sheath.The physician had to make a horizontal cut in the plastic protector to be able to put it back into the catheter.A preface sheath 8f, u.S.Catalog 301803m was used.The introducer stuck/slipped within the sheath issue is considered a reportable event.The biosense webster, inc.Product analysis lab received the product on february 11, 2019.The initial visual inspection revealed that there was no physical damage.The part that is thought to have been cut by the customer was still on the shaft.Per the information provided when the event was initially reported, the damage on the introducer was intentionally cut by the customer in order to re-engage the catheter.
|
|
Manufacturer Narrative
|
Additional information was received on february 13, 2019 about the facility, therefore, initial reporter section has been updated to provide the facility name and address.Manufacturer's reference # (b)(4).
|
|
Manufacturer Narrative
|
It was reported that a patient underwent an atrial tachycardia procedure with a pentaray nav high-density mapping eco catheter, and the introducer was stuck and slipped within the sheath.The physician had difficulty passing the pentaray nav high-density mapping eco catheter in the 8f introducer.When the catheter was removed, the protector became stuck in the introducer.The physician had to cut off the protection to re-engage the catheter and again tried to pass it over to the mobicath, which was also unsuccessful.The pentaray nav high-density mapping eco catheter still did not progress.When the pentaray protector was replaced by the smarttouch protector, the catheter progressed normally.The procedure was completed successfully.There was no patient consequence.Additional information was received on the event clarifying that protector was found dislodged inside the sheath.The physician had to make a horizontal cut in the plastic protector to be able to put it back into the catheter.A preface sheath 8f, u.S.Catalog 301803m was used.The device was inspected, and it was found in normal condition.The insertion tool was cut by the customer, then, the insertion was measured, and it was found within specifications.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was not confirmed.The root cause of the issue reported cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.Manufacturer's reference # (b)(4).
|
|
Search Alerts/Recalls
|
|
|