MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

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

Patient Problem Fever (1858)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported the patient who had percutaneous coronary intervention (pci) and insertion of the intra-aortic balloon(iab) on july 10 had developed fever 3 days later.The iab was removed july 12.Patient has been treated with intravenous (iv) antibiotics and recovering well.

Event Description

It was reported the patient who had percutaneous coronary intervention (pci) and insertion of the intra-aortic balloon(iab) on july 10 had developed fever 3 days later.The iab was removed (b)(6) 2020.Patient has been treated with intravenous (iv) antibiotics and recovering well.

Manufacturer Narrative

Corrections for mfg report number 2248146-2020-00462 / tw 358471 section b - date of event.From: [blank] to: (b)(6) 2020.Section d - brand name.From: unknown iab.To: linear 7.5 fr 34cc iab.Section d - lot # from: unknown.To: 3000113519.Section d - exp.Date from: [blank] to: 11/27/2022.Section d catalog #.From: unknown to: 0684-00-0474.Section d - udi number from: [blank] to: (b)(4).Section h - manufacture date from: [blank] to: 11/27/2019.Additional information: the device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.There is currently a field action# res 85823 in process that is related to this event.There was no reported malfunction.All the failure modes are addressed in the risk file.No labeling review can be completed as there was no reported malfunction.There were no crf/capa/scar/nmcr identified for "no reported malfunction".The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #(b)(4) h3 other text : device not returned.

Manufacturer Narrative

Additional information: section d - device available for eval? from: yes to: no section h - evaluation method codes added: device discarded; 4115 the device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.Reference complaint #(b)(4).

Event Description

It was reported the patient who had percutaneous coronary intervention (pci) and insertion of the intra-aortic balloon(iab) on (b)(6) had developed fever 3 days later.The iab was removed (b)(6).Patient has been treated with intravenous (iv) antibiotics and recovering well.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10517703
• MDR Text Key: 206503999
• Report Number: 2248146-2020-00462
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2022
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000113519
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other