MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DEF 7F NOGA,2P,D,.5MM,HYP,FUSE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number 120707S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant products: myostar, us catalog #: unknown, lot #: unknown; noga-star, us catalog #: 120708s, lot #: 17550617m.(b)(4).

Event Description

It was reported that a patient underwent a myocardial injection procedure for congestive heart failure with nogastar catheters x 2 and suffered pain requiring nitroglycerin.After cardiac injection, the patient reported chest pain.Nitroglycerin was administered.No further interventions were required.Patient remained hospitalized overnight per protocol.Patient was reported to be in stable condition.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical/surgical intervention or prolonged hospitalization to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 1/15/18.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.Originally it was reported that the lot number was "unknown".However, during the bwi failure analysis lab evaluation, the lot number of 17624305m was determined.Still pending is the manufactured date and expiration date.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Correction to 3500a follow-up #1.On follow-up #1 it was reported that on (b)(6) 2018, the (b)(6) failure analysis lab received the nogastar catheter for evaluation.During evaluation, the lot # was determined.Therefore, we updated the lot # from ¿unknown¿ to ¿17624305m¿.However, after further review, the product received was not the nogastar catheter.The product received was the myostar which was listed as a concomitant product.We previously reported the myostar concomitant product information as ¿unknown¿ for the us catalog # and lot #.The updated concomitant product information for the myostar is us catalog # 121120si and lot # 17624305m.Also, correction to the lot # for the reportable product of the nogastar catheter.It should reflect as ¿unknown¿.The nogastar catheter has not been received for analysis at this time.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

The biosense webster failure analysis lab received the device for evaluation on 3/5/2018.Additional information was received on the event on 3/5/2018, stating that the chest pain started on the day of procedure, (b)(6) 2017, and lasted intermittently until (b)(6) 2017.Therefore, updated date of event.Originally it was reported that the lot number was "unknown".However, additional information was received on 3/5/2018 providing the lot number of 17545524m.Therefore, lot has been populated.The manufactured date and expiration date have been provided and fields.Expiration date, manufactured date have been populated.Investigation summary: it was reported that a patient underwent a myocardial injection procedure for congestive heart failure with nogastar catheters x 2 and suffered pain requiring nitroglycerin.After cardiac injection, the patient reported chest pain.Nitroglycerin was administered.No further interventions were required.Patient remained hospitalized overnight per protocol.Patient was reported to be in stable condition.Upon receipt, the product was visually inspected and it was found in normal conditions.Deflection and carto test were performed and the system passed all specifications.No error found.Product is working properly.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

After further review, additional testing was performed on this device.Therefore, the investigation summary has been updated on 11/21/2018.Investigation summary: it was reported that a patient underwent a myocardial injection procedure for congestive heart failure with nogastar catheters x 2 and suffered pain requiring nitroglycerin.After cardiac injection, the patient reported chest pain.Nitroglycerin was administered.No further interventions were required.Patient remained hospitalized overnight per protocol.Patient was reported to be in stable condition.Upon receipt, the product was visually inspected and it was found in normal conditions.Deflection, electrical and carto test were performed and system passed all specification.No error was found.Product is working properly.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Added method codes of "analysis of production records".Manufacturer¿s reference number: (b)(4).

• Brand Name: DEF 7F NOGA,2P,D,.5MM,HYP,FUSE
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7177214
• MDR Text Key: 96811755
• Report Number: 2029046-2018-01041
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K954390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 120707S
• Device Lot Number: 17545524M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 12/13/2017; 12/13/2017; 03/05/2018; 11/21/2018
• Supplement Dates FDA Received: 02/06/2018; 02/09/2018; 09/23/2018; 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention